Chemoradiotherapy and SHR-1701 in Patients With Unresectable Gastric Cancer

NCT07689851 | Recruiting Phase 2

• 1 other identifier: 26/320-6044
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Gastric Cancer (GC); Gastroesophageal Junction Adenocarcinoma

Keywords

Radiotherapy; CAPOX; SHR-1701; Immunotherapy; Chemotherapy; Unresectable gastric cancer; Metastatic gastric cancer; Locally advanced gastric cancer; PD-L1/TGF-β bispecific antibody

Outcome Measures

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.

  Up to 12 months

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  up to 12 months

• Overall Survival (OS)

  up to 3 years

• Local Control Rate (LCR)

  up to 3 years

• Pathological Complete Response (pCR)

  up to 24 months

• Major Pathological Response (MPR)

  up to 24 months

Study Arms (1)

Radiotherapy + CAPOX + SHR-1701

EXPERIMENTAL

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.

Drug: COPOX; Radiation: Radiotherapy; Biological: SHR-1701

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 + CAPOX + SHR-1701

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.

Radiotherapy + CAPOX + SHR-1701

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.

Radiotherapy + CAPOX + SHR-1701

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG performance status of 0-1.
• At least one measurable lesion according to RECIST version 1.1.
• Adequate organ function, including:
• Hemoglobin ≥90 g/L;
• White blood cell count ≥3.5 × 10⁹/L;
• Absolute neutrophil count ≥1.5 × 10⁹/L;
• Platelet count ≥100 × 10⁹/L;
• Serum creatinine ≤1.0 × upper limit of normal (ULN);
• Blood urea nitrogen (BUN) ≤1.0 × ULN;
• Alanine aminotransferase (ALT) ≤1.5 × ULN;
• Aspartate aminotransferase (AST) ≤1.5 × ULN;

You may not qualify if:

• 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.
• Conditions associated with an increased risk of gastrointestinal perforation, including active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis, or other known risk factors.
• History of another malignancy, except adequately treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
• Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or unstable cardiac arrhythmia.
• Any physical examination findings, laboratory abnormalities, or uncontrolled medical conditions that, in the investigator's judgment, may interfere with study outcomes or increase the risk of treatment-related complications.
• Pregnant or breastfeeding women.
• Congenital or acquired immunodeficiency, including HIV infection, or a history of organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Active hepatitis B infection (HBV DNA ≥2,000 IU/mL), active hepatitis C infection, or active tuberculosis.
• Receipt of any live or other prohibited vaccines within 4 weeks before study treatment. Seasonal inactivated influenza vaccines are permitted, whereas intranasal live attenuated influenza vaccines are not permitted.
• Concurrent treatment with other immunosuppressive agents, chemotherapy, investigational drugs, or long-term systemic corticosteroids.
• Psychiatric disorders, substance abuse, or social conditions that may compromise treatment compliance, as determined by the investigator.
• Known hypersensitivity or contraindication to any study treatment.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (3)

Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Hospital

Shenzhen, Guangdong, China

RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

RECRUITING

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

Beijing, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Radiotherapy; SHR-1701

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jing Jin, M.D.

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Jin, M.D.

CONTACT

15650735818; jinjing@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will receive induction CAPOX plus SHR-1701 followed by radiotherapy and subsequent combination therapy according to the study protocol.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2029
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)