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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
COPOX
DrugCAPOX 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
RadiationRadiotherapy 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/VaccineSHR-1701 (1800 mg) will be administered intravenously on day 1 or each 21-day cycle (Q3W) according to the study protocol.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Radiotherapy + CAPOX + SHR-1701Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from initiation of study treatment to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Time frame
Up to 12 monthsSecondary outcomes
1
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants achieving a complete response or partial response according to RECIST version 1.1.
Time frame
up to 12 months2
Overall Survival (OS)
Overall survival is defined as the time from initiation of study treatment to death from any cause.
Time frame
up to 3 years3
Local Control Rate (LCR)
Local control rate is defined as the proportion of participants without local disease progression within the irradiated lesions
Time frame
up to 3 years4
Pathological Complete Response (pCR)
The proportion of participants with no residual viable tumor cells in the resected specimen following neoadjuvant treatment.
Time frame
up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov