cancer
Conditions
Interventions
Other tumors group:Camrelizumab
Stage IV lung cancer:Camrelizumab treatment
esophageal cancer group:Camrelizumab treatment
Sponsors
Shanxi Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 ~ 75 years men and women; 2. Patients diagnosed with stage IV malignant tumors by clinical pathology; 3. Patients have 1-5 metastases (anywhere); 4. The investigator determined that the patient could receive Camrelizumab; 5. no autoimmune disease; 6. have not previously received PD-1 / PD-L1 inhibitors; 7. Patients with curative effect evaluation of PR and SD after receiving radical radiotherapy; 8. with measurable lesions ( long diameter of tumor lesions by CT scan >=10 mm, short diameter of lymph node lesions by CT scan >=15 mm , and scan layer thickness not greater than 5 mm) 9. PS score: 0 ~ 1; 10. Expected survival >=12 weeks; 11. The function of important organs meets the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the start of research treatment): (1) Routine blood test, which must meet (no blood transfusion within 14 days): Absolute neutrophil count (ANC) >=1.5x10^9/L; Platelets >=100x10^9/L; Hemoglobin >=9 g/dL; (2) Biochemical inspection must meet the following standards: Serum albumin >=2.8 g/dL; Bilirubin <=1.5*ULN, ALT and AST <=2.5*ULN; if liver metastases exist, ALT and AST <= 5*ULN; Serum Cr<=1*ULN, endogenous creatinine clearance =50mL/min (Cockcroft-Gault formula); 12. Female subjects of fertility should undergo a urine or serum pregnancy test within 72 hours before receiving the first study drug administration and prove to be negative, and are willing to administer Camrelizumab during the test period to the last Use effective methods of contraception within 3 months. For male subjects whose partners are women of childbearing age, effective contraception should be used during the trial and within 3 months after the last administration of Camrelizumab; 13. Patients voluntarily joined the study and signed an informed consent form (ICF) with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. with diffuse brain metastases and meningeal metastases; 2. Have any active autoimmune disease or have a history of autoimmune diseases, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, reduced thyroid function (hormonal replacement Can be included after normal treatment); 3. Asthmatic patients who need bronchodilators for medical intervention; 4. Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) clinically significant supraventricular Or patients with ventricular arrhythmias requiring clinical intervention; 5. Have active infection or fever of unknown origin during the screening period and before the first administration> 38.5 degree C (in the judgment of the researcher, the fever caused by the tumor can be included in the group); 6. Known history or evidence of interstitial lung disease or active non-infectious pneumonia; 7. with congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA >=10^4 copies / mL) or hepatitis C (positive to hepatitis C antibody, and HCV-RNA is above the lower limit of detection of the analytical method); 8. Have previously received other PD-1 monoclonal antibody therapy or other immunotherapy against PD-1 / PD-L1; 9. known to be allergic to macromolecular protein preparations, or to any carelizumab component; 10. Subjects requiring systemic treatment with corticosteroids (> 10 mg / day prednisone effective dose) or other immunosuppressants within 14 days of first study drug use. In the absence of active autoimmune diseases, inhaled or topical use of steroids and adrenocortical hormone replacement at doses> 10 mg / day of prednisone; 11. Received an anti-tumor monoclonal antibody (mAb) within 4 weeks prior to first use of the study drug, or adverse events caused by the previously received drug have not recovered (ie = 1 grade or reached baseline level). Note: Except for subjects who have <=grade 2 neuropathy or <=grade 2 hair loss, if the subject has undergone major surgery, the toxic reactions and / or complications caused by their surgical intervention must be fully recovered before starting treatment. 12. are participating in other clinical studies; 13. Live vaccines were given within 4 weeks before the first use of the study drug. Inactivated virus vaccines for seasonal influenza, injections are allowed, but live attenuated influenza vaccines for nasal use are not allowed; 14. According to the researcher's judgment, the subject has other factors that may lead to the termination of the study. For example, if the subject has other serious diseases (including mental illness) that require combined treatment, serious laboratory test values, family or social factors, may Conditions that affect subject safety or trial data collection; 15. Investigators judge other situations that are not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;safety; | — |
Countries
China
Contacts
Public ContactHongwei Li
Shanxi Provincial Cancer Hospital
Outcome results
None listed