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JS107 in Combination With Toripalimab and Chemotherapy for the Treatment of CLDN18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

NCT07584135 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-05-13

No results posted yet for this study

Summary

This study is a multicenter, randomized, open-label, controlled Phase III clinical trial aimed at evaluating the efficacy and safety of JS107 combined with toripalimab XELOX versus sintilimab combined with XELOX as first-line treatment for patients with advanced G/GEJ adenocarcinoma.

The research subjects were patients with unresectable locally advanced, recurrent or metastatic G/GEJ adenocarcinoma who were CLDN18.2-positive and HER2-negative and had not received systemic treatment before (except for neoadjuvant/adjuvant therapy that occurred more than 6 months after disease progression/recurrence from the last treatment). The study took BICR-PFS and OS as Dual primary endpoints.

Conditions

  • Gastric Adenocarcinoma

Interventions

DRUG

Injection JS107&Toripalimab& Oxaliplatin Injection& Capecitabine

JS107: 2 mg/kg on day 1 Q3W; Toripalimab (T): 240 mg on day 1 Q3W. Capecitabine (C): 750 mg/m² BID Day1-Day14, Q3W，Oxaliplatin 100mg/m² on Day1 Q3W, Maximum of 6 cycles.

DRUG

Sintilimab& Oxaliplatin Injection& Capecitabine

Sintilimab: 3 mg/kg or 200 mg Day1 Q3W, Capecitabine: 1000 mg/m² BID Day1-Day14, Q3W，Oxaliplatin 130mg/m² on Day1 Q3W, Maximum of 6 cycles.

Sponsors & Collaborators

  • NingBo Junyan Hongshi Biosciences Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2029-01-31
Completion
2029-12-31

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 NCT07584135 on ClinicalTrials.gov