Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma

• Status: Recruiting
• Trial end date: 2027-10-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with PD-1 inhibitors and chemoradiotherapy, in comparison with adjuvant chemotherapy only, in D2/R0 resected pN3 gastric or gastroesophageal junction adenocarcinoma. PD-1+CRT cohort: A total of 216 patients will receive 6 weeks of PD-1 inhibitors and chemotherapy, then receive concurrent chemoradiotherapy, followed by 6 weeks of PD-1 inhibitors and chemotherapy, finally receive maintenance treatment of PD-1 inhibitors until (maximum 1year after radiotherapy). CT cohort: A total of 217 patients will receive 6 months of chemotherapy. The disease-free survival(DFS), overall survival(OS) and adverse effects will be analyzed.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Capecitabine; Immune Checkpoint Inhibitors; Oxaliplatin; Tegafur

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

• Patients with expected survival time more than 6 months

• Patients after standard D2/R0 resection

• Postoperative histologically confirmed adenocarcinoma of the stomach or GEJ

• Positive lymph nodes more than 7, stage pN3

• Patients without distant metastasis (M0) or M1 with abdominal exfoliated cell detection positive (CY1P0)

• Patients' physical condition and visceral function allows following adjuvant therapy, including chemotherapy, chemoradiotherapy and PD-1 inhibitor therapy.

• Patients' blood routine and biochemical indicators should meet the following standard:

Hb≥90g/L, ANC≥1.5*10^9/L, PLT≥100*10^9/L, ALT & AST≤2.5 U/L, TB ≤ 1.5 UNL, serum creatinine<1 UNL.

• Patients who are willing to obey regimens during the study.

• Written informed consent is acquired before random entry, and patients should know that he/she has the right to quit, and following treatment won't be affected.

• Patients are willing to provide samples of blood and tissue.

Exclusion Criteria:

• Patients with gross peritoneal metastasis (CY1P0 excluded) or distant metastasis.

• Patients who has received any anti-tumor therapy before surgery.

• Patients who had received radiotherapy for abdominal organs including stomach, liver, kidney, etc.

• Patients who had active systematic autoimmune diseases which need systematic treatment within 2 years before first medication in the study, substitutive therapy (such as thyroxine, insulin, etc) excluded.

• Patients diagnosed with immunodeficiency, or was receiving systematic glucocorticoid treatment or other immunosuppressive therapy within 7 days before medication, physiological dose of glucocorticoid is allowed (≤10 mg/d prednison or equivalent medication)

• Patients who have known severe allergic reaction (≥level 3) to anti-PD-1 monoclonal antibody, 5-FU, Oxaliplatin or any auxiliary material.

• Patient diagnosed with other malignant tumor in the past 5 years, excluding radical basal cell carcinoma of the skin and/or radical resected carcinoma in situ.

• Patient with severe vital organ failure.

• Pregnant or lactation period

• Patient with known mental illness or drug abuse that may influence compliance.

• Patient with known HIV infection, or active tuberculosis.

• Untreated active hepatitis B

• Patient with active HCV infection

• Uncontrolled complications

• Other situations that might disturb study results and compliance.