Gastric cancer
Conditions
Interventions
single arm:camrelizumab combined with SOX
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged >= 18 years; 2. Histological or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma; 3. No serious liver and kidney damage, the functional level of the organ must meet the following requirements: ANC >= 1.5 x 10^9 / L; PLT >= 90 x 10^9 / L; Hb >=90 g / L; TBIL = 50 mL / min (Cockcroft-Gault formula); LVEF >= 50%; QT interval (QTcF) corrected by Fridricia method: male = 3 months; 7. The investigator evaluates that the patient can comply with the protocol requirements; 8. Sign the informed consent document.
Exclusion criteria
Exclusion criteria: 1. Systemic cytotoxic chemotherapy for advanced (metastatic) disease; 2. There is evidence of disease progression within 6 months after neoadjuvant chemotherapy or adjuvant cytotoxic chemotherapy (or both) or radiotherapy for cancer of the gastric or gastroesophageal junction; 3. Patients with allergic or hypersensitive constitution to treatment drugs, and patients with autoimmune diseases; Has received allograft/solid organ transplantation; 4. Third interstitial effusion (such as large amounts of pleural and ascites) that cannot be controlled by drainage or other means; 5. Use of steroids for more than 50 days, or long-term use of steroids is required; 6. Radiotherapy within 30 days prior to the first dose of study drug therapy (within 2 weeks, palliative care for peripheral bone metastases and recovery from all toxicity); 7. Uncontrolled symptomatic brain metastases or mental abnormalities that cannot properly represent subjective symptoms; 8. According to the researchers' judgment, the abnormal blood coagulation function has clinical significance, has bleeding tendency or is receiving thrombolytic or anticoagulant therapy; 9. Receive any other antitumor therapy, including antitumor Chinese patent medicines and immunopreparations; 10. Residual toxicity (e.g., grade >= 2 in the blood system, cardiovascular system or neurotoxicity) is present in previously received treatment. Hair loss is allowed; 11. Inability to swallow, chronic diarrhea and intestinal obstruction, with multiple factors affecting drug administration and absorption; 12. Other malignant tumors (other than GC) occurred within the first 5 years of enrollment, except carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin previously treated for the purpose of radical resection; 13. Pregnant or nursing women who are fertile but refuse to use contraception; 14. A history of serious heart disease or disease, including: a documented history of congestive heart failure, high-risk uncontrolled arrhythmia, angina requiring medication, clinically defined valvular disease, a history of severe myocardial infarction, and refractory hypertension; 15. According to the judgment of the researcher, there are serious concomitant diseases (such as uncontrolled hypertension, diabetes, thyroid disease, etc.) that endanger the safety of patients or affect the completion of the study; 16. Other circumstances that the investigator determined were not appropriate for inclusion in the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;AE; | — |
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactZhengxiang Han
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed