Gastric cancer
Conditions
Interventions
Experimental group:the combination of PD-1 mab and chemotherapy
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical research; Fully understand and be informed of this study, and sign the Informed Consent Form (ICF); Willing to follow and capable of completing all testing procedures. 2. There is no gender limit, and the age at the time of signing the ICF is = 18 years old. 3. Gastroesophageal junction (GEJ) adenocarcinoma (including Signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by histology or cytology, locally advanced unresectable, recurrent or metastatic, or that the patient refuses surgery. Note: Except for relapsed patients who have received (new) adjuvant chemotherapy/adjuvant radiotherapy, other patients have not received systematic therapy in the past. 4. The time from the end of previous (new) adjuvant chemotherapy/radiotherapy to the recurrence of the disease is more than 6 months. 5. There are target lesions that have been confirmed by imaging to meet the Response Evaluation Criteria In Solid Tumours (RECIST). 6. The ECOGPS score within 7 days before the first medication is 0-1. 7. The main organs function is normal, that is, they meet the following standards (they have not received blood transfusion, albumin, recombinant human Thrombopoietin or Colony-stimulating factor (CSF) treatment within 14 days before the first drug use) a. Blood routine White blood cell (WBC) normal value range Neutrophils (NE) normal value range Platelets (PLT) = 100 × 10 ^ 9/L Hemoglobin (Hb) = 90g/L b. Blood biochemistry (liver and kidney function) Total bilirubin (TBIL) = 1.5 × Upper limit of normal value (ULN) Alanine aminotransferase (ALT) = 2.5 × Upper limit of normal value (ULN) Asparagus cochinchinensis aminotransferase (AST) = 2.5 × Upper limit of normal value (ULN) Albumin = 25g/L Creatinine (Cr) = 1.5 × Upper limit of normal value (ULN) c. Coagulation function (no transfusion of blood products within 14 days before treatment) Activated partial thromboplastin time (APTT) = 1.5 × Upper limit of normal value (ULN) Prothrombin time (PT) = 1.5 × Upper limit of normal value (ULN) International standardized ratio (INR) = 1.5 × Upper limit of normal value (ULN) 8. When female patients were enrolled, they were: • The results of serum Pregnancy test within 7 days before the first medication must be negative; • Except for patients who have undergone menopause (defined as no menstruation for at least 1 year and no other confirmed cause other than menopause) or have undergone surgical sterilization (removal of ovaries and/or uterus), Patients with Fertility must meet the following requirements at the same time: sign the informed consent form and agree to use contraceptives with an annual failure rate of less than 1% at least 6 months after the last administration of treatment (contraceptives with an annual failure rate of less than 1% include bilateral Tubal ligation, male sterilization, correct use of hormone contraceptives that can inhibit ovulation, hormone releasing intrauterine devices and copper containing intrauterine devices) or keep abstinence (avoid heterosexual sex) ; • Do not breastfeed. 9. Male patients must comply with the following requirements: consent to abstinence (avoiding heterosexual intercourse) or use contraceptive measures. The contraceptive measures are as follows: when the partner is a woman of childbearing age or the partner is pregnant, male patients mus
Exclusion criteria
Exclusion criteria: 1. Within 5 years or simultaneously suffering from other active malignant tumors. Cured local tumors, such as skin Basal-cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate Carcinoma in situ, cervical Carcinoma in situ, breast Carcinoma in situ, can be included in the group. 2. Known to have a history of severe allergies to any monoclonal antibody or study drug excipients. 3. Patients who need to be treated with Corticosteroid (>10mg/day therapeutic dose of prednisone) or other immunosuppressive drugs within 14 days before the first administration or during the study. But the following situations are allowed for enrollment: in the absence of active autoimmune diseases, patients are allowed to use topical or inhaled steroids, or adrenal hormone replacement therapy with a dose = 10mg/day of prednisone. 4. There are known active or suspected autoimmune diseases (including but not limited to: Autoimmune hepatitis, Uveitis, enteritis, hepatitis, hypophysitis, Vasculitis, nephritis, Hyperthyroidism, hypothyroidism). Except those who were in stable state of the disease at the time of enrollment (no systemic Immunosuppressive drug treatment is required). 5. HIV infection. 6. Chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500IU/mL, or those infected with active hepatitis C (HCV). 7. Within 14 days before the first medication, any active infection that requires systematic anti infective treatment occurs; Except for preventive antibiotic treatment (such as prevention of Urinary tract infection or chronic obstructive pulmonary disease). 8. Suffer from active pulmonary tuberculosis. 9. Patients who had interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe lung function damage, etc. previously or currently, which may interfere with the detection and management of suspected drug-related pulmonary toxicity. 10. If it is related to refractory Pleural effusion or ascites, such as Pleural effusion or ascites, it needs to be punctured and drained within 2 weeks before the first administration. 11. Hypertension that is difficult to control through medication (systolic blood pressure = 160mmHg, diastolic blood pressure = 90mmHg). 12. Myocardial infarction and poorly controlled arrhythmia (including QTc interval = 450ms for males and = 470ms for females) occurred within 6 months before the first medication (QTc interval calculated using Fridericia formula). 13. There is NYHA standard ?~? cardiac insufficiency or color Doppler echocardiography: LVEF (Left Ventricular Ejection Fraction)<50%. 14. Patients with brain metastasis, cancerous meningitis, spinal cord compression or brain disease or Pia mater disease found in CT or MRI during screening. 15. Live vaccine or Attenuated vaccine shall be inoculated within 28 days before the first administration, or live vaccine or Attenuated vaccine shall be inoculated within the study period, excluding COVID-19 vaccine and Influenza vaccine. 16. Patients who are preparing to undergo or have previously received organ or bone marrow transplantation. 17. Major surgery, open biopsy or major traumatic injury 28 days before the first administration or major surgery is expected during treatment. 18. Known history of abuse or drug use of psychotropic substances; Patients who have stopped drinking can be enrolled. 19. Patients who may increase the risk of participating in research and drug use, or have other severe, acute, and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Normalized Protein expression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;progression free survival;Overall survival;Incidence of adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactHao Wu
Jiangsu Province Hospital
Outcome results
None listed