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RECRUITING
NCT07689851
PHASE2

Chemoradiotherapy and SHR-1701 in Patients With Unresectable Gastric Cancer

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

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.

Official title: Safety and Efficacy of Radiotherapy Combined With Chemotherapy and SHR-1701, a PD-L1(Programmed Death-Ligand 1)/TGF-β(Transforming Growth Factor-beta) Bispecific Antibody, in the Treatment of Unresectable Locally Advanced or Metastatic Gastric Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-07-01

Completion Date

2029-07-30

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DRUG

COPOX

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.

RADIATION

Radiotherapy

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.

BIOLOGICAL

SHR-1701

SHR-1701 (1800 mg) will be administered intravenously on day 1 or each 21-day cycle (Q3W) according to the study protocol.

Locations (3)

Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Hospital

Shenzhen, Guangdong, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China