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PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer

NCT05180734 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 878

Last updated 2025-01-15

No results posted yet for this study

Summary

This multicenter, randomized, double-blind phase III study intends to recruit about 878 patients, including PD-L1 positive 660 patients, who have received radical gastrectomy (R0 resection, D2 or more extended lymphadenectomy) with postoperative pathological stage IIB or III (AJCC Cancer Staging Manual, 8th Edition) gastric or EGJ adenocarcinoma to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.

Conditions

  • Gastric or Esophagogastric Junction Adenocarcinoma

Interventions

BIOLOGICAL

JS001/Placebo

JS001/placebo combine with Postoperative Adjuvant Chemotherapy

BIOLOGICAL

JS001/placebo combine with Postoperative Adjuvant Chemotherapy

JS001/placebo combine with Postoperative Adjuvant Chemotherapy

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2026-06-30
Completion
2028-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180734 on ClinicalTrials.gov