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.
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