Actively Recruiting
Neoadjuvant Radiotherapy Plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)
Led by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Updated on 2025-09-10
40
Participants Needed
1
Research Sites
283 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neoadjuvant radiotherapy plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)
CONDITIONS
Official Title
Neoadjuvant Radiotherapy Plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign written informed consent
- Age 18 years or older, any gender
- Histologically confirmed HER2-negative gastric or gastroesophageal junction adenocarcinoma (Siewert type II or III with 62 cm esophageal involvement)
- Cancer stage IIA to III, resectable
- Willing to provide fresh blood, feces, and tumor tissue samples for biomarker analysis
- Eastern Cooperative Oncology Group performance status 0 or 1
- Expected survival time of at least 3 months
- No previous anti-tumor therapy including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or interventional therapy (excluding diagnostic abdominal exploration)
- Adequate blood, kidney, liver, and coagulation function as defined by specific laboratory values
- Negative serum pregnancy test for women of childbearing age within 7 days before first treatment
- Women of childbearing age and male patients with partners of childbearing potential agree to use effective contraception during treatment and for 180 days after last administration
You will not qualify if you...
- Received palliative local treatment or systemic non-specific immunomodulatory therapy within 2 weeks before first treatment
- Previous treatment with immune checkpoint inhibitors, immune agonists, or immune cell therapy
- History of gastrointestinal perforation or fistula within 6 months (unless fully recovered)
- Active inflammatory bowel disease or severe gastrointestinal conditions affecting drug absorption
- Active malignant tumors within past 3 years except certain cured localized tumors
- Active or untreated brain metastases or leptomeningeal disease unless stable and asymptomatic after treatment
- Pleural, pericardial effusion or ascites requiring frequent drainage
- Active autoimmune diseases requiring systemic treatment within 2 years except specified stable conditions
- Recent serious cardio-cerebrovascular events or conditions within specified timeframes
- Unresolved toxicity from previous cancer therapy above specified severity
- Grade 2 or higher peripheral neuropathy
- Known symptomatic interstitial lung disease or non-infectious pneumonia requiring systemic steroids
- Active tuberculosis or recent systemic anti-infective therapy
- History of organ or stem cell transplantation
- Active hemoptysis, diverticulitis, abscess, gastrointestinal obstruction, or significant bleeding within 1 month
- Recent major surgery other than gastric cancer diagnosis within 28 days
- Active hepatitis B or C infection without appropriate treatment
- History of immunodeficiency or HIV positive
- Active syphilis infection
- Concurrent participation in another clinical trial unless only observational or follow-up
- Recent systemic glucocorticoid or immunosuppressive drug use above specified doses except allowed uses
- Live vaccine within 30 days before first treatment or planned during study
- History of severe allergy to monoclonal antibodies
- Mental illness or substance abuse impairing compliance
- Known allergy or hypersensitivity to study drugs or components
- Pregnancy or breastfeeding
- Any condition posing risk or interfering with study evaluation as judged by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Army Medical Center
Chongqing, Other (Non U.s.), China, 400000
Actively Recruiting
Research Team
B
Bin Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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