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 (Jun 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
Treatments studied
Chemotherapy
Other
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.
Frequently asked questions
Is NCT04997837 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage PN3 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages