Chemoradiotherapy and SHR-1701 in Patients With Unresectable Gastric Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
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.
Eligibility criteria
Qualifiers
Male or female participants aged 18 to 75 years.
Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
Unresectable locally advanced or metastatic gastric cancer, with primary and metastatic lesions amenable to radiotherapy (excluding patients with brain metastases or extensive metastatic disease).
HER2-negative disease.
Disqualifiers
Brain metastases or extensive metastatic disease.
Prior treatment with PD-1, PD-L1, TGF-β, CTLA-4 inhibitors, or other investigational immunotherapies.
Severe autoimmune diseases, including but not limited to active inflammatory bowel disease (Crohn's disease or ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or autoimmune vasculitis (e.g., Wegener's granulomatosis).
Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis.
Trial design
Treatments tested in this trial
- COPOX
- Radiotherapy
- SHR-1701
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov