Gastric cancer
Conditions
Interventions
experimental group:Camrelizumab+Trastuzumab+CapeOX
Sponsors
Department of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients voluntarily participate in this study and sign the informed consent form; 2) Age >= 18 years and = 1.5 x 10^9/L; platelet >= 80 x 10^9/L; hemoglobin >= 90 g/L; (2) Chemistry panel meeting the following criteria: Total bilirubin 50ml/min (male: endogenous creatinine clearance = (140-age) x body weight)/(72 x serum Cr); female: endogenous creatinine clearance = (140-age) x body weight )/(72 x serum Cr) x 0.85; body weight unit: kg; serum Cr unit: mg/mL); 6) Patients with the measurable disease; evaluated by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1); 7) Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1; 8) Life expectancy >= 6 months; 9) Investigator assesses patient's ability to comply with protocol requirements; 10) Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose, Willing to use highly effective methods of contraception during the trial and for 90 days after treatment. Male subjects with partners who are surgically sterile or agree to use highly effective methods of contraception during the trial and for 90 days;
Exclusion criteria
Exclusion criteria: 1) Previous systemic cytotoxic chemotherapy for advanced (metastatic) disease; 2) Patients with evidence of disease progression within 6 months after completion of neoadjuvant chemotherapy or adjuvant chemotherapy (or both) or radiotherapy for gastric cancer or gastroesophageal junction cancer; 3) Previous treatment with any HER2-targeted drug (including but not limited to trastuzumab, lapatinib, pyrrolidone, lenalidomide, etc.); 4) Prior treatment with PD-1/PD-L1 antibody, CTLA-4 antibody, or other therapy directed against PD-1/PD-L1. 5) Patients with allergy or hypersensitive constitution to therapeutic drugs; 6) Patients with current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia that may interfere with the judgment and treatment of immune-related pulmonary toxicity, or subjects with active pneumonia or severe lung function impairment on screening CT; active pulmonary tuberculosis; 7) Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or complete remission of asthma in childhood, requiring no intervention after adulthood can be included; patients with asthma requiring medical intervention with bronchodilators can not be included); 8) Clinically significant abnormal coagulation function, bleeding tendency or receiving thrombolytic or anticoagulant therapy as judged by the investigator; 9) Patients with severe heart disease or medical history, including: a documented history of congestive heart failure, high-risk uncontrolled arrhythmia, angina pectoris requiring drug treatment, clinically clear valvular heart disease, a history of severe myocardial infarction and resistant hypertension; 10) Previous allogeneic tissue/solid organ transplant. 11) According to the investigator's judgment, there are concomitant diseases that seriously jeopardize the patient's safety or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.); 12) Other conditions not suitable for inclusion in the study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;Safety; | — |
Countries
China
Contacts
Public ContactPan Hongming, Zheng Yu
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed