OncoMatch/Clinical Trials/NCT04997837
Study of Adjuvant Chemotherapy With or Without PD-1 Inhibitors and Chemoradiotherapy in Resected pN3 Gastric (G) or GEJ Adenocarcinoma
Is NCT04997837 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for gastric cancer.
Treatment: PD-1 inhibitor · Oxaliplatin · Capecitabine · Tegafur-gimeracil-oteracil potassium · 5-FU · Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Disease stage
Required: Stage PN3
Positive lymph nodes more than 7, stage pN3
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — D2/R0 resection
Patients after standard D2/R0 resection
Cannot have received: anti-tumor therapy
Exception: surgery
Patients who has received any anti-tumor therapy before surgery.
Cannot have received: radiotherapy
Patients who had received radiotherapy for abdominal organs including stomach, liver, kidney, etc.
Lab requirements
Blood counts
hb ≥ 90 g/l, anc ≥ 1.5*10^9/l, plt ≥ 100*10^9/l
Kidney function
serum creatinine < 1 unl
Liver function
alt & ast ≤ 2.5 u/l, tb ≤ 1.5 unl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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