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
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the use of neoadjuvant radiotherapy combined with immunochemotherapy to treat patients with locally advanced gastric or gastroesophageal junction adenocarcinoma that can be surgically removed. The study is a randomized, two-arm, prospective trial aiming to evaluate the safety and effectiveness of these treatments before surgery. Patients with specific stages of this cancer and HER2-negative status are included to explore improved outcomes using this combined approach. Participants are divided into two groups. Group A receives radiotherapy first (30 Gy in 10 fractions) followed by six cycles of combined chemotherapy (SOX regimen) with the immunotherapy drugs Iparomlimab and Tuvonralimab administered intravenously at 5 mg/kg every three weeks. Group B starts with three cycles of the combined immunochemotherapy, then radiotherapy, and then another three cycles of the same immunochemotherapy. Surgery is performed 4 to 6 weeks after completing treatment. If surgery is not possible, immunochemotherapy continues until disease progression, with options for second-line treatments as needed. Throughout the study, participants provide blood, feces, and tumor samples before and after surgery to analyze biomarkers using advanced techniques like single-cell sequencing and spatial transcriptomic or proteomic analysis. Researchers assess outcomes including pathological complete response, major pathologic response, objective response rate, disease control rate, progression-free survival, overall survival, and clinical complete response over periods ranging from months to years. Long-term survival follow-up is conducted to monitor patient outcomes and safety.
CONDITIONS
Brief 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 informed consent before study procedures
- Age 18 years or older, any gender
- Histologically confirmed HER2-negative gastric or gastroesophageal junction adenocarcinoma (Siewert type II or III with 2 cm esophageal involvement) staged IIA to III and resectable
- Willing to provide fresh blood, feces, and tumor tissue samples of adequate quality for biomarker analysis
- Eastern Cooperative Oncology Group performance status score of 0 or 1
- Expected survival time of at least 3 months
- No prior anti-tumor therapy including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, or traditional Chinese medicine with anti-tumor effects
- Adequate organ function as defined by specified blood counts, kidney, liver, and coagulation parameters
- Negative serum pregnancy test for women of childbearing age and agreement to use effective contraception during and up to 180 days after treatment
- Male patients with female partners of childbearing age must agree to use effective contraception during and up to 180 days after treatment
You will not qualify if you...
- Received palliative local treatment within 2 weeks before first administration or systemic non-specific immunomodulatory therapy within 2 weeks
- Previous treatment with immune checkpoint inhibitors, immune cell therapy, or other immune-targeting treatments
- History of gastrointestinal perforation or fistula within 6 months unless healed and stable
- Active inflammatory bowel disease or severe gastrointestinal conditions affecting drug use
- Active malignant tumors within past 3 years except certain cured local tumors
- Active or untreated brain metastases or related central nervous system diseases unless stable and asymptomatic
- Symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage
- Active autoimmune diseases requiring treatment within 2 years, except stable or mild conditions
- Significant cardiovascular diseases or risk factors within specified timeframes
- Unresolved toxicity from prior cancer therapy above certain grades
- Known interstitial lung disease, symptomatic or requiring steroid treatment
- Active tuberculosis or recent systemic anti-infective therapy within 2 weeks
- History of allogeneic organ or stem cell transplantation
- Clinical active bleeding or bleeding tendencies within 1 month
- Major surgery within 28 days before first administration
- Untreated active hepatitis B or C infection
- Known immunodeficiency or HIV positive status
- Active syphilis infection
- Participation in another clinical study unless observational follow-up
- Recent systemic glucocorticoid or immunosuppressive therapy above specified doses
- Live vaccine within 30 days before first administration or planned during study
- Severe hypersensitivity to monoclonal antibodies
- Mental illness or substance abuse interfering with trial participation
- Allergy or hypersensitivity to study drugs or components
- Pregnancy or breastfeeding
- Any condition judged by researchers to pose risk or interfere with evaluation or safety
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 to 18 weeks until surgery (including radiotherapy and 6 cycles of immunochemotherapy)
Participants receive neoadjuvant radiotherapy and immunochemotherapy following one of two treatment sequences depending on their assigned group, including radiotherapy and cycles of chemotherapy combined with immunotherapy.
Multiple treatment visits over several weeks including radiotherapy sessions and chemotherapy infusions
Duration - 1 day for surgery plus immediate post-operative care
Participants undergo surgery 4 to 6 weeks after completing neoadjuvant treatment for tumor removal.
1 surgical visit and post-operative hospital stay
Duration - Up to 3 years or longer as part of survival follow-up
Participants are followed long-term after surgery to monitor survival and disease progression, including biomarker testing from blood, feces, and tissue samples.
Periodic visits for assessments and sample collection over several years
Trial Site Locations
Total: 1 location
1
Army Medical Center
Chongqing, Other (Non U.s.), China, 400000
Actively Recruiting
Research Team
B
Bin Wang
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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