the microsatellite highly unstable (msi-h) advanced solid tumor
Conditions
Interventions
SHR-1210 200mg:SHR-1210 200mg IV
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
17 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old, male or female; 2. A malignant solid tumor diagnosed by histology or cytology, with a partial advanced stage can not resection or metastasis; And the detection of tumor tissue by a third party confirmed MSI-H or dMMR; 3. Treatment of failed patients with first-line system chemotherapy (with the treatment of first-line chemotherapy for tumor standard) or radical concurrent chemoradiotherapy (which can contain platinum-type or purple unlined upper class).Definition of treatment failure: accept a wire system during chemotherapy or radical chemoradiation therapy or disease progression after treatment, there must be a radiographic evidence or clinical evidence (such as new hair malignant chest water) prove that disease progression.For neoadjuvant/adjuvant therapy (chemotherapy or radiotherapy), if the disease progresses within 6 months after treatment or cessation of treatment, it should be considered a first-line treatment failure; 4. According to therapeutic effect evaluation standard of solid tumor (RECIST1.1), with at least one measurable lesions, measurable lesions should be not received radiotherapy, etc, in the usual radiation area of the target lesions, if confirm progress, and meet RECIST1.1 standard, can also be selected as a target lesions); 5. Tissue samples should be provided for molecular pathologic analysis, choose the newly acquired organization. if newly acquired tissue could not be provided, the patients could provide the acquired tissue with 10 sheets of paraffin sections that were preserved in the archive; 6. ECOG 0-1; 7. The expected survival period is greater than 12 weeks; 8. The function of vital organs meets the following requirements (no blood ingredients and cell growth factors are allowed to be used for the first 2 weeks of treatment): The neutrophil absolute count (ANC) =1.5 x 10^9/L; Platelets = 75 x 10^9/L; Hemoglobin = 9g/dL; Serum albumin =2.8g/dL; Bilirubin is less than or equal to 1.5 times ULN, ALT and AST are less than or equal to 2.5 times ULN; If there is a liver metastasis, ALT and AST are less than or equal to 5 times ULN; Creatinine clearance rate = 50mL/min; 9. Women with fertility should be carried out within 72 hours of urine or serum pregnancy test before accepting first study drug dosage, and prove to negative, and willing to use effective methods of contraception to the last dose of SHR - 1210 after three months during the study. For male subjects with a partner of childbearing age, effective method of contraception should be adopted during the study and within three months of the last dose of SHR-1210.;Inclusion criteria: 1. Aged 18 to 75 years old, male or female; 2. A malignant solid tumor diagnosed by histology or cytology, with a partial advanced stage can not resection or metastasis; And the detection of tumor tissue by a third party confirmed MSI-H or dMMR; 3. Treatment of failed patients with first-line system chemotherapy (with the treatment of first-line chemotherapy for tumor standard) or radical concurrent chemoradiotherapy (which can contain platinum-type or purple unlined upper class).Definition of treatment failure: accept a wire system during chemotherapy or radical chemoradiation therapy or disease progression after treatment, there must be a radiographic evidence or clinical evidence (such as new hair malignant chest water) prove that disease progression.For neoadjuvant/adjuvant therapy (chemotherapy or radiotherapy), if the disease progresses within 6 months after treatment or cessation of treatment, it should be considered a first-line treatment failure; 4. According to therapeutic effect evaluation standard of solid tumor (RECIST1.1), with at least one measurable lesions, measurable lesions should be not received radiotherapy, etc, in the usual radiation area of the target lesions, if confirm progress, and meet RECIST1.1 standard, can also be selected as a target lesions); 5. Tissue samples should be provided for molecular pathologic analysis, choose the newly acquired organization. if newly acquired tissue could not be provided, the patients could provide the acquired tissue with 10 sheets of paraffin sections that were preserved in the archive; 6. ECOG 0-1; 7. The expected survival period is greater than 12 weeks; 8. The function of vital organs meets the following requirements (no blood ingredients and cell growth factors are allowed to be used for the first 2 weeks of treatment): The neutrophil absolute count (ANC) =1.5 x 10^9/L; Platelets = 75 x 10^9/L; Hemoglobin = 9g/dL; Serum albumin =2.8g/dL; Bilirubin is less than or equal to 1.5 times ULN, ALT and AST are less than or equal to 2.5 times ULN; If there is a liver metastasis, ALT and AST are less than or equal to 5 times ULN; Creatinine clearance rate = 50mL/min; 9. Women with fertility should be carried out within 72 hours of urine or serum pregnancy test before accepting first study drug dosage, and prove to negative, and willing to use effective methods of contraception to the last dose of SHR - 1210 after three months during the study. For male subjects with a partner of childbearing age, effective method of contraception should be adopted during the study and within three months of the last dose of SHR-1210.;Inclusion criteria: 1. Aged 18 to 75 years old, male or female; 2. A malignant solid tumor diagnosed by histology or cytology, with a partial advanced stage can not resection or metastasis; And the detection of tumor tissue by a third party confirmed MSI-H or dMMR; 3. Treatment of failed patients with first-line system chemotherapy (with the treatment of first-line chemotherapy for tumor standard) or radical concurrent chemoradiotherapy (which can contain platinum-type or purple unlined upper class).Definition of treatment failure: accept a wire system during chemotherapy or radical chemoradiation therapy or disease progression after treatment, there must be a radiographic evidence or clinical evidence (such as new hair malignant chest water) prove that disease progression.For neoadjuvant/adjuvant therapy (chemotherapy or radiotherapy), if the disease progresses within 6 months after treatment or cessation of treatment, it should be considered a first-line treatment failure; 4. According to therapeutic effect evaluation standard of solid tumor (RECIST1.1), with at least one measurable lesions, measurable lesions should be not received radiotherapy, etc, in the usual radiation area of the target lesions, if confirm progress, and meet RECIST1.1 standard, can also be selected as a target lesions); 5. Tissue samples should be provided for molecular pathologic analysis, choose the newly acquired organization. if newly acquired tissue could not be provided, the patients could provide the acquired tissue with 10 sheets of paraffin sections that were preserved in the archive; 6. ECOG 0-1; 7. The expected survival period is greater than 12 weeks; 8. The function of vital organs meets the following requirements (no blood ingredients and cell growth factors are allowed to be used for the first 2 weeks of treatment): The neutrophil absolute count (ANC) =1.5 x 10^9/L; Platelets = 75 x 10^9/L; Hemoglobin = 9g/dL; Serum albumin =2.8g/dL; Bilirubin is less than or equal to 1.5 times ULN, ALT and AST are less than or equal to 2.5 times ULN; If there is a liver metastasis, ALT and AST are less than or equal to 5 times ULN; Creatinine clearance rate = 50mL/min; 9. Women with fertility should be carried out within 72 hours of urine or serum pregnancy test before accepting first study drug dosage, and prove to negative, and willing to use effective methods of contraception to the last dose of SHR - 1210 after three months during the study. For male subjects with a partner of childbearing age, effective method of contraception should be adopted during the study and within three months of the last dose of SHR-1210.;Inclusion criteria: 1. Aged 18 to 75 years old, male or female; 2. A malignant solid tumor diagnosed by histology or cytology, with a partial advanced stage can not resection or metastasis; And the detection of tumor tissue by a third party confirmed MSI-H or dMMR; 3. Treatment of failed patients with first-line system chemotherapy (with the treatment of first-line chemotherapy for tumor standard) or radical concurrent chemoradiotherapy (which can contain platinum-type or purple unlined upper class).Definition of treatment failure: accept a wire system during chemotherapy or radical chemoradiation therapy or disease progression after treatment, there must be a radiographic evidence or clinical evidence (such as new hair malignant chest water) prove that disease progression.For neoadjuvant/adjuvant therapy (chemotherapy or radiotherapy), if the disease progresses within 6 months after treatment or cessation of treatment, it should be considered a first-line treatment failure; 4. According to therapeutic effect evaluation standard of solid tumor (RECIST1.1), with at least one measurable lesions, measurable lesions should be not received radiotherapy, etc, in the usual radiation area of the target lesions, if confirm progress, and meet RECIST1.1 standard, can also be selected as a target lesions); 5. Tissue samples should be provided for molecular pathologic analysis, choose the newly acquired organization. if newly acquired tissue could not be provided, the patients could provide the acquired tissue with 10 sheets of paraffin sections that were preserved in the archive; 6. ECOG 0-1; 7. The expected survival period is greater than 12 weeks; 8. The function of vital organs meets the following requirements (no blood ingredients and cell growth factors are allowed to be used for the first 2 weeks of treatment): The neutrophil absolute count (ANC) =1.5 x 10^9/L; Platelets = 75 x 10^9/L; Hemoglobin = 9g/dL; Serum albumin =2.8g/dL; Bilirubin is less than or equal to 1.5 times ULN, ALT and AST are less than or equal to 2.5 times ULN; If there is a liver metastasis, ALT and AST are less than or equal to 5 times ULN; Creatinine clearance rate = 50mL/min; 9. Women with fertility should be carried out within 72 hours of urine or serum pregnancy test before accepting first study drug dosage, and prove to negative, and willing to use effective methods of contraception to the last dose of SHR - 1210 after three months during the study. For male subjects with a partner of childbearing age, effective method of contraception should be adopted during the study and within three months of the last dose of SHR-1210.;Inclusion criteria: 1. Aged 18 to 75 years old, male or female; 2. A malignant solid tumor diagnosed by histology or cytology, with a partial advanced stage can not resection or metastasis; And the detection of tumor tissue by a third party confirmed MSI-H or dMMR; 3. Treatment of failed patients with first-line system chemotherapy (with the treatment of first-line chemotherapy for tumor standard) or radical concurrent chemoradiotherapy (which can contain platinum-type or purple unlined upper class).Definition of treatment failure: accept a wire system during chemotherapy or radical chemoradiation therapy or disease progression after treatment, there must be a radiographic evidence or clinical evidence (such as new hair malignant chest water) prove that disease progression.For neoadjuvant/adjuvant therapy (chemotherapy or radiotherapy), if the disease progresses within 6 months after treatment or cessation of treatment, it should be considered a first-line treatment failure; 4. According to therapeutic effect evaluation standard of solid tumor (RECIST1.1), with at least one measurable lesions, measurable lesions should be not received radiotherapy, etc, in the usual radiation area of the target lesions, if confirm progress, and meet RECIST1.1 standard, can also be selected as a target lesions); 5. Tissue samples should be provided for molecular pathologic analysis, choose the newly acquired organization. if newly acquired tissue could not be provided, the patients could provide the acquired tissue with 10 sheets of paraffin sections that were preserved in the archive; 6. ECOG 0-1; 7. The expected survival period is greater than 12 weeks; 8. The function of vital organs meets the following requirements (no blood ingredients and cell growth factors are allowed to be used for the first 2 weeks of treatment): The neutrophil absolute count (ANC) =1.5 x 10^9/L; Platelets = 75 x 10^9/L; Hemoglobin = 9g/dL; Serum albumin =2.8g/dL; Bilirubin is less than or equal to 1.5 times ULN, ALT and AST are less than or equal to 2.5 times ULN; If there is a liver metastasis, ALT and AST are less than or equal to 5 times ULN; Creatinine clearance rate = 50mL/min; 9. Women with fertility should be carried out within 72 hours of urine or serum pregnancy test before accepting first study drug dosage, and prove to negative, and willing to use effective methods of contraception to the last dose of SHR - 1210 after three months during the study. For male subjects with a partner of childbearing age, effective method of contraception should be adopted during the study and within three months of the last dose of SHR-1210.
Exclusion criteria
Exclusion criteria: Patients with any of the following cannot be enrolled in the study: 1. subjects has been diagnosed as other malignant tumor five years before first use of the study drug, except for the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or breast cancer; 2. CNS metastases; 3. subjects have a history of any active autoimmune disease or autoimmune disease(e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, myocarditis, nephritis, thyroid function, thyroid function decrease (hormone replacement therapy after the normal accepted)).Patients with vitiligo or asthma in childhood have been fully relieved and adults without any intervention can be included, Patients with asthma who need bronchial amplifiers for medical intervention are not included; 4. Subjects Have failed to control the heart of the clinical symptoms or disease, such as: (1) the NYHA class II heart failure (2)unstable angina pectoris (3)myocardial infarction occurred within 1 year (4) Patients with clinically significant ventricular or ventricular arrhythmia requiring clinical intervention; 5. With active infection or unexplained fever > 38.5 dgree C occurred during the screening or before the first time to give medicine (the investigator determined that the subjects were allowed to enter the group due to the fever caused by the tumor); 6. History or evidence of interstitial pulmonary disease or active non-infectious pneumonia; 7. Sbujects with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis b (hbv-dna is greater than 104 copies/ml) or hepatitis c (positive for hepatitis c antibody, and HCV-RNA is higher than the reference value of analytical method); 8. Other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-l1 have been accepted; 9. Known to be allergic to macromolecular proteins or to any SHR-1210 ingredients; 10. Subjects who were treated with corticosteroids (> 10mg/day prednisone) or other immunosuppressive agents were required for the first 14 days prior to the first use of the research drug.In the absence of active autoimmune disease, inhalation or partial use of steroids and doses of > 10mg/day prednisone in the efficacy dose of adrenocortical hormone replacement; 11. Subjects had used antitumor monoclonal antibody (mAb), chemotherapy, targeted small molecules or radiation therapy within 4 weeks before first use of study drugs, or adverse events caused by previously accepted drugs have not recovered (grade 1 or baseline level) or less.Note: Subjects with no more than 2 levels of neuropathy or 2 levels of hair loss were excluded.If the subjects underwent major surgery, the toxicity and/or complications of their surgical intervention must be fully restored prior to treatment; 12. Subjects are participating in other clinical studies or subjects has participated in other clinical studies for the first four weeks before the first use of the study drug (the participants who have been in the follow-up period were evaluated with the last use of experimental drugs or equipment); 13. A live vaccine was administered within four weeks of the first study of the drug.It is allowed to accept the inactivated virus vaccine against seasonal influenza and inactivated virus vaccine for injection, but it is not allowed to accept the attenuated live influenza vaccine with the nasal use; 14.;Exclusion criteria: Patients with any of the following cannot be enrolled in the study: 1. subjects has been diagnosed as other malignant tumor five years before first use of the study drug, except for the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or breast cancer; 2. CNS metastases; 3. subjects have a history of any active autoimmune disease or autoimmune disease(e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, myocarditis, nephritis, thyroid function, thyroid function decrease (hormone replacement therapy after the normal accepted)).Patients with vitiligo or asthma in childhood have been fully relieved and adults without any intervention can be included, Patients with asthma who need bronchial amplifiers for medical intervention are not included; 4. Subjects Have failed to control the heart of the clinical symptoms or disease, such as: (1) the NYHA class II heart failure (2)unstable angina pectoris (3)myocardial infarction occurred within 1 year (4) Patients with clinically significant ventricular or ventricular arrhythmia requiring clinical intervention; 5. With active infection or unexplained fever > 38.5 dgree C occurred during the screening or before the first time to give medicine (the investigator determined that the subjects were allowed to enter the group due to the fever caused by the tumor); 6. History or evidence of interstitial pulmonary disease or active non-infectious pneumonia; 7. Sbujects with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis b (hbv-dna is greater than 104 copies/ml) or hepatitis c (positive for hepatitis c antibody, and HCV-RNA is higher than the reference value of analytical method); 8. Other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-l1 have been accepted; 9. Known to be allergic to macromolecular proteins or to any SHR-1210 ingredients; 10. Subjects who were treated with corticosteroids (> 10mg/day prednisone) or other immunosuppressive agents were required for the first 14 days prior to the first use of the research drug.In the absence of active autoimmune disease, inhalation or partial use of steroids and doses of > 10mg/day prednisone in the efficacy dose of adrenocortical hormone replacement; 11. Subjects had used antitumor monoclonal antibody (mAb), chemotherapy, targeted small molecules or radiation therapy within 4 weeks before first use of study drugs, or adverse events caused by previously accepted drugs have not recovered (grade 1 or baseline level) or less.Note: Subjects with no more than 2 levels of neuropathy or 2 levels of hair loss were excluded.If the subjects underwent major surgery, the toxicity and/or complications of their surgical intervention must be fully restored prior to treatment; 12. Subjects are participating in other clinical studies or subjects has participated in other clinical studies for the first four weeks before the first use of the study drug (the participants who have been in the follow-up period were evaluated with the last use of experimental drugs or equipment); 13. A live vaccine was administered within four weeks of the first study of the drug.It is allowed to accept the inactivated virus vaccine against seasonal influenza and inactivated virus vaccine for injection, but it is not allowed to accept the attenuated live influenza vaccine with the nasal use; 14.;Exclusion criteria: Patients with any of the following cannot be enrolled in the study: 1. subjects has been diagnosed as other malignant tumor five years before first use of the study drug, except for the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or breast cancer; 2. CNS metastases; 3. subjects have a history of any active autoimmune disease or autoimmune disease(e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, myocarditis, nephritis, thyroid function, thyroid function decrease (hormone replacement therapy after the normal accepted)).Patients with vitiligo or asthma in childhood have been fully relieved and adults without any intervention can be included, Patients with asthma who need bronchial amplifiers for medical intervention are not included; 4. Subjects Have failed to control the heart of the clinical symptoms or disease, such as: (1) the NYHA class II heart failure (2)unstable angina pectoris (3)myocardial infarction occurred within 1 year (4) Patients with clinically significant ventricular or ventricular arrhythmia requiring clinical intervention; 5. With active infection or unexplained fever > 38.5 dgree C occurred during the screening or before the first time to give medicine (the investigator determined that the subjects were allowed to enter the group due to the fever caused by the tumor); 6. History or evidence of interstitial pulmonary disease or active non-infectious pneumonia; 7. Sbujects with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis b (hbv-dna is greater than 104 copies/ml) or hepatitis c (positive for hepatitis c antibody, and HCV-RNA is higher than the reference value of analytical method); 8. Other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-l1 have been accepted; 9. Known to be allergic to macromolecular proteins or to any SHR-1210 ingredients; 10. Subjects who were treated with corticosteroids (> 10mg/day prednisone) or other immunosuppressive agents were required for the first 14 days prior to the first use of the research drug.In the absence of active autoimmune disease, inhalation or partial use of steroids and doses of > 10mg/day prednisone in the efficacy dose of adrenocortical hormone replacement; 11. Subjects had used antitumor monoclonal antibody (mAb), chemotherapy, targeted small molecules or radiation therapy within 4 weeks before first use of study drugs, or adverse events caused by previously accepted drugs have not recovered (grade 1 or baseline level) or less.Note: Subjects with no more than 2 levels of neuropathy or 2 levels of hair loss were excluded.If the subjects underwent major surgery, the toxicity and/or complications of their surgical intervention must be fully restored prior to treatment; 12. Subjects are participating in other clinical studies or subjects has participated in other clinical studies for the first four weeks before the first use of the study drug (the participants who have been in the follow-up period were evaluated with the last use of experimental drugs or equipment); 13. A live vaccine was administered within four weeks of the first study of the drug.It is allowed to accept the inactivated virus vaccine against seasonal influenza and inactivated virus vaccine for injection, but it is not allowed to accept the attenuated live influenza vaccine with the nasal use; 14.;Exclusion criteria: Patients with any of the following cannot be enrolled in the study: 1. subjects has been diagnosed as other malignant tumor five years before first use of the study drug, except for the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or breast cancer; 2. CNS metastases; 3. subjects have a history of any active autoimmune disease or autoimmune disease(e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, myocarditis, nephritis, thyroid function, thyroid function decrease (hormone replacement therapy after the normal accepted)).Patients with vitiligo or asthma in childhood have been fully relieved and adults without any intervention can be included, Patients with asthma who need bronchial amplifiers for medical intervention are not included; 4. Subjects Have failed to control the heart of the clinical symptoms or disease, such as: (1) the NYHA class II heart failure (2)unstable angina pectoris (3)myocardial infarction occurred within 1 year (4) Patients with clinically significant ventricular or ventricular arrhythmia requiring clinical intervention; 5. With active infection or unexplained fever > 38.5 dgree C occurred during the screening or before the first time to give medicine (the investigator determined that the subjects were allowed to enter the group due to the fever caused by the tumor); 6. History or evidence of interstitial pulmonary disease or active non-infectious pneumonia; 7. Sbujects with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis b (hbv-dna is greater than 104 copies/ml) or hepatitis c (positive for hepatitis c antibody, and HCV-RNA is higher than the reference value of analytical method); 8. Other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-l1 have been accepted; 9. Known to be allergic to macromolecular proteins or to any SHR-1210 ingredients; 10. Subjects who were treated with corticosteroids (> 10mg/day prednisone) or other immunosuppressive agents were required for the first 14 days prior to the first use of the research drug.In the absence of active autoimmune disease, inhalation or partial use of steroids and doses of > 10mg/day prednisone in the efficacy dose of adrenocortical hormone replacement; 11. Subjects had used antitumor monoclonal antibody (mAb), chemotherapy, targeted small molecules or radiation therapy within 4 weeks before first use of study drugs, or adverse events caused by previously accepted drugs have not recovered (grade 1 or baseline level) or less.Note: Subjects with no more than 2 levels of neuropathy or 2 levels of hair loss were excluded.If the subjects underwent major surgery, the toxicity and/or complications of their surgical intervention must be fully restored prior to treatment; 12. Subjects are participating in other clinical studies or subjects has participated in other clinical studies for the first four weeks before the first use of the study drug (the participants who have been in the follow-up period were evaluated with the last use of experimental drugs or equipment); 13. A live vaccine was administered within four weeks of the first study of the drug.It is allowed to accept the inactivated virus vaccine against seasonal influenza and inactivated virus vaccine for injection, but it is not allowed to accept the attenuated live influenza vaccine with the nasal use; 14.;Exclusion criteria: Patients with any of the following cannot be enrolled in the study: 1. subjects has been diagnosed as other malignant tumor five years before first use of the study drug, except for the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or breast cancer; 2. CNS metastases; 3. subjects have a history of any active autoimmune disease or autoimmune disease(e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, myocarditis, nephritis, thyroid function, thyroid function decrease (hormone replacement therapy after the normal accepted)).Patients with vitiligo or asthma in childhood have been fully relieved and adults without any intervention can be included, Patients with asthma who need bronchial amplifiers for medical intervention are not included; 4. Subjects Have failed to control the heart of the clinical symptoms or disease, such as: (1) the NYHA class II heart failure (2)unstable angina pectoris (3)myocardial infarction occurred within 1 year (4) Patients with clinically significant ventricular or ventricular arrhythmia requiring clinical intervention; 5. With active infection or unexplained fever > 38.5 dgree C occurred during the screening or before the first time to give medicine (the investigator determined that the subjects were allowed to enter the group due to the fever caused by the tumor); 6. History or evidence of interstitial pulmonary disease or active non-infectious pneumonia; 7. Sbujects with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis b (hbv-dna is greater than 104 copies/ml) or hepatitis c (positive for hepatitis c antibody, and HCV-RNA is higher than the reference value of analytical method); 8. Other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-l1 have been accepted; 9. Known to be allergic to macromolecular proteins or to any SHR-1210 ingredients; 10. Subjects who were treated with corticosteroids (> 10mg/day prednisone) or other immunosuppressive agents were required for the first 14 days prior to the first use of the research drug.In the absence of active autoimmune disease, inhalation or partial use of steroids and doses of > 10mg/day prednisone in the efficacy dose of adrenocortical hormone replacement; 11. Subjects had used antitumor monoclonal antibody (mAb), chemotherapy, targeted small molecules or radiation therapy within 4 weeks before first use of study drugs, or adverse events caused by previously accepted drugs have not recovered (grade 1 or baseline level) or less.Note: Subjects with no more than 2 levels of neuropathy or 2 levels of hair loss were excluded.If the subjects underwent major surgery, the toxicity and/or complications of their surgical intervention must be fully restored prior to treatment; 12. Subjects are participating in other clinical studies or subjects has participated in other clinical studies for the first four weeks before the first use of the study drug (the participants who have been in the follow-up period were evaluated with the last use of experimental drugs or equipment); 13. A live vaccine was administered within four weeks of the first study of the drug.It is allowed to accept the inactivated virus vaccine against seasonal influenza and inactivated virus vaccine for injection, but it is not allowed to accept the attenuated live influenza vaccine with the nasal use; 14.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;mOS;EORTC QLQ-C30;AE; | — |
Countries
China
Contacts
Public ContactYong Gao;Yong Gao;Yong Gao;Yong Gao;Yong Gao ;;;;
Shanghai East Hospital;Shanghai East Hospital;Shanghai East Hospital;Shanghai East Hospital;Shanghai East Hospital
Outcome results
None listed