Gastric Cancer (GC)Phase 2NCT07689851
Chemoradiotherapy and SHR-1701 in Patients With Unresectable Gastric Cancer
A Phase 2 study testing COPOX, Radiotherapy and SHR-1701 in people with Gastric Cancer (GC) and Gastroesophageal Junction Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer (GC), Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- COPOX, Radiotherapy and SHR-1701
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2026to 30 Jul 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 24Show fewer
- 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;
- Alkaline phosphatase (ALP) ≤1.5 × ULN;
- Total bilirubin (TBIL) ≤1.5 × ULN;
- Negative urine protein;
- Normal coagulation function.
- No contraindications to immunotherapy.
- No history of hypersensitivity to fluoropyrimidines or platinum-based agents.
- No prior surgery, chemotherapy, immunotherapy, or other antitumor therapy for gastric or gastroesophageal junction cancer since diagnosis.
- No previous radiotherapy to the intended irradiation sites.
- Ability to understand and willingness to sign a written informed consent form.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Jing Jin, M.D., 15650735818
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Hospital
Shenzhen, Guangdong
Jing Jin, M.D., 15650735818
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi
Jing Jin, M.D., 15650735818
About this study
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
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.
Read the detailed description
The investigators are conducting a clinical research study to evaluate the efficacy and safety of radiotherapy combined with CAPOX and SHR-1701 for patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The study hypothesizes that radiotherapy combined with CAPOX and SHR-1701, a PD-L1/TGF-β bispecific antibody, may improve clinical outcomes compared with the current standard first-line treatment. The primary objective is to evaluate progression-free survival (PFS). Secondary objectives include objective response rate (ORR), overall survival (OS), local control rate (LCR), R0 resection rate, pathological complete response (pCR), major pathological response (MPR), treatment-related adverse events, and quality of life. The trial will enroll 60 participants across multiple study centers. Eligible participants will receive radiotherapy combined with CAPOX and SHR-1701, followed by SHR-1701 maintenance therapy when appropriate. Exploratory analyses will evaluate potential biomarkers associated with treatment response and survival. This study aims to provide a safe and effective first-line treatment strategy for patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Being tested
- COPOX, Radiotherapy, SHR-1701
- Keywords
- Radiotherapy, CAPOX, SHR-1701, Immunotherapy, Chemotherapy, Unresectable gastric cancer, Metastatic gastric cancer, Locally advanced gastric cancer, PD-L1/TGF-β bispecific antibody
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPOXDrug
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.
RadiotherapyRadiation
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-1701Biological
SHR-1701 (1800 mg) will be administered intravenously on day 1 or each 21-day cycle (Q3W) according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: COPOX; Radiation: Radiotherapy; Biological: SHR-1701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (9)
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.
Measured: up to 12 months
Overall Survival (OS)
Overall survival is defined as the time from initiation of study treatment to death from any cause.
Measured: up to 3 years
Local Control Rate (LCR)
Local control rate is defined as the proportion of participants without local disease progression within the irradiated lesions
Measured: up to 3 years
Pathological Complete Response (pCR)
The proportion of participants with no residual viable tumor cells in the resected specimen following neoadjuvant treatment.
Measured: up to 24 months
Major Pathological Response (MPR)
The proportion of participants with ≤ 10% residual viable tumor cells in the resected primary tumor.
Measured: up to 24 months
Treatment-Related Adverse Events
The incidence and severity of treatment-related adverse events will be assessed according to CTCAE version 5.0.
Measured: up to 24 months
Quality of Life
Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.
Measured: up to 3 years
Exploratory Biomarker Analysis
Exploratory analyses will quantify biomarker concentrations, count participants presenting biomarker alterations linked to treatment response, and calculate survival rates stratified by biomarker levels. All measured biomarker values, participant counts, and stratified survival rates will be summarized and presented in the outcome measure results data table.
Measured: up to 3 years
R0 Resection Rate
The proportion of participants who undergo curative-intent surgery and achieve microscopically margin-negative (R0) resection
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will receive induction CAPOX plus SHR-1701 followed by radiotherapy and subsequent combination therapy according to the study protocol.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, JIN JING, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Jing Jin, M.D., Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689851
- Sponsor's protocol ID
- 26/320-6044
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No