Advanced gastric cancer
Conditions
Interventions
experimental group:camrelizumab plus apatinib and SOX
Sponsors
Shandong Cancer Prevention and Treatment Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old, no gender limit; 2. Patient who has advanced gastric or gastroesophageal junction adenocarcinoma diagnosed by pathology or histology, with measurable lesions (according to the RECIST 1.1 standard, CT scan of tumor lesions has a long diameter =10mm, and a CT scan of lymph node lesions with a short diameter >= 15mm); 3. Advanced patients who have not received any systemic treatment; 4. According to the following definition of laboratory test results, there is sufficient hematology and end-organ function, these test results need to be completed within 7 days before the first study treatment: Blood routine: absolute neutrophil count (ANC) >= 1.5 x 10 ^ 9/L, and did not receive granulocyte colony stimulating factor supportive therapy within 14 days before the first study treatment; platelet count (PLT) >= 100 x 10 ^ 9/L, and No blood transfusion within 14 days before the first study treatment; lymphocyte count (LC) >= 0.5x10 ^ 9/L; hemoglobin (Hb) >= 90g/L; Liver function: aspartate transferase (AST) and alanine aminotransferase (ALT)= 3 g/dL; Renal function: creatinine clearance rate (CrCl) >= 4mL/minute (using Cockcroft-Gault formula); Blood coagulation function: international normalized ratio (INR) = 50%. 5. ECOG PS: 0-1 points; 6. The expected survival period is >= 3 months; 7. The patient is able to understand and sign the informed consent form (when the subject loses the capacity, his guardian will sign it on his behalf).
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or a history of autoimmune disease; 2. The subjects who has any Cardiac clinical symptoms or diseases are not well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Supraventricular with clinical significance Or ventricular arrhythmia requires treatment or intervention; (5) QTc > 450ms (male); QTc > 470ms (female); 3. Subjects who have previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy, after the completion of the treatment (last medication), less than 4 weeks before the study medication (or 5 drug half-lives, whichever is longer); patients whose adverse events (except hair loss) caused by previous treatment have not recovered to <= CTCAE 1 degree; 4. Cortisol (greater than 10 mg/day of prednisone or equivalent dose) or other systemic immunosuppressive drugs (except inhaled or topical corticosteroids) or doses greater than 10 mg/day need to be used within 14 days before study treatment Prednisone or the equivalent of replacement therapy; 5. Patients with active infection or unexplainable fever higher than 38.5 degrees C within 2 weeks before the first medication; 6. Past and current patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 7. Have received PD-1, PD-L1, CTLA-4 and other antibody treatments; 8. Live vaccines may be vaccinated within 4 weeks before the study medication or may be administered during the study period; 9. According to the judgment of the investigator, the subject has other factors that may cause the study to be terminated midway, such as other serious diseases (including mental illness) that require combined treatment, severe laboratory abnormalities, and family or Social and other factors will affect the safety of subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;Safety;QoL; | — |
Countries
China
Contacts
Public ContactShu Zhang
Shandong Cancer Hospital
Outcome results
None listed