Gastric cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed gastric adenocarcinoma (GC) or gastroesophageal junction adenocarcinoma GEJ); Gastroscopy tissue specimens and serum specimens can be obtained before treatment; 2.Staged as stage IV according to the 8th edition of AJCC; some locally advanced patients evaluated by researchers as inoperable directly can also be enrolled after full communication; 3. Aged 18–75 years, regardless of gender; 4. Patients are able to take oral medications; 5. ECOG score of 0–1; 6. With measurable lesions meeting the criteria of RECIST 1.1; 7. No previous treatment for advanced gastric cancer (including chemotherapy, targeted therapy, or immunotherapy); 8. No active autoimmune diseases, no active hepatitis B, and no HIV infection; 9. No need to receive systemic corticosteroids (exceeding the equivalent dose of 10 mg/day prednisone) or other immunosuppressive drugs during treatment; 10. Bone marrow, liver, kidney, heart, lung, and nervous system functions, etc., are judged by clinicians to be tolerable to chemotherapy, targeted therapy, immunotherapy, and surgical treatment; 11. Regularly receive efficacy evaluation, and those who achieve conversion success will receive surgical treatment; 12. Expected survival time of more than 3 months; 13. Women of childbearing age must have taken reliable contraceptive measures and be willing to use appropriate contraceptive methods during the trial and within 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate contraceptive methods or have undergone surgical sterilization during the trial and within 8 weeks after the last administration of the trial drug; 14. Voluntarily agree to participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with confirmed allergy to the trial drug and/or its excipients; 2. Patients with active gastric bleeding and Hb 1.5, or prothrombin time (PT) > upper limit of normal (ULN) + 4 s, or activated partial thromboplastin time (APTT) > 1.5 ULN], with bleeding tendency or receiving thrombolytic or anticoagulant therapy; 10. Patients who have participated in other clinical trials within 4 weeks; 11. Patients who are deemed inappropriate to be included in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion success rate of surgical resection; R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response;Objective Response Rate;Overall Survival; | — |
Countries
China
Contacts
The First Affiliated Hospital of Anhui Medical University