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

Recruiting Phase 3 Interventional Study
Gastric Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
433 (estimated)
Sponsor
Fudan University · Other
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About This Trial
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 chemorad…
Trial Locations
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Eligibility 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 …
Contacts

Zhen Zhang, MD, PhD

18801735029

zhen_zhang@fudan.edu.cn

CONTACT