Chemoradiotherapy and SHR-1701 in Patients With Unresectable Gastric Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT07689851
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastric Cancer (GC)
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • COPOX — DRUG
    CAPOX consists of oxaliplatin (130 mg/m²) administered intravenously on day 1 and capecitabine (1,000 mg/m²) administered orally twice daily on days 1-14 of each 21-day cycle (Q3W) according to the study protocol.
  • Radiotherapy — RADIATION
    Radiotherapy will be delivered to the primary tumor (30 Gy in 10 fractions) and metastatic lesions (25-35 Gy in 5-7 fractions), with the dose determined according to the location, number, and size of metastatic lesions and normal tissue dose constraints in accordance with the study protocol.
  • SHR-1701 — BIOLOGICAL
    SHR-1701 (1800 mg) will be administered intravenously on day 1 or each 21-day cycle (Q3W) according to the study protocol.

Study Details

Gastric Cancer is one of the leading causes of cancer-related death worldwide, and patients with unresectable locally advanced or metastatic disease have a poor prognosis. This study aims to evaluate the safety and efficacy of radiotherapy combined with CAPOX and SHR-1701, a PD-L1/TGF-β bispecific antibody, in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. By improving local tumor control and enhancing systemic antitumor activity, this study seeks to increase the opportunity for curative-intent resection and improve survival outcomes in patients with advance gastric cancer.

Key Dates

First listed
Jul 8, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jul 30, 2028
Completion
Jul 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiotherapy + CAPOX + SHR-1701
    Participants will receive induction CAPOX plus SHR-1701, followed by radiotherapy and additional CAPOX plus SHR-1701 combination therapy. Participants who become eligible for surgery may undergo curative-intent resection, followed by SHR-1701 maintenance therapy when appropriate.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 12 months ]

Central Contacts

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