OncoMatch/Clinical Trials/NCT07165847
Neoadjuvant Radiotherapy Plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)
Is NCT07165847 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Iparomlimab and Tuvonralimab and Oxaliplatin for immunotherapy.
Treatment: Iparomlimab and Tuvonralimab · Oxaliplatin · Tegafur — Neoadjuvant radiotherapy plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) negative
HER2-negative gastric or gastroesophageal junction adenocarcinoma
Disease stage
Required: Stage IIA, IIB, IIIA, IIIB, IIIC, III (AJCC 8th edition)
AJCC 8th edition staging of Stage IIA- Stage III, i.e., T1- 2N+, and T3-4 and or N+, and resectable
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: abdominal exploration for diagnostic staging
No previous anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and traditional Chinese medicine with clear anti-tumor effects, excluding abdominal exploration for diagnostic staging)
Cannot have received: radiotherapy
Exception: abdominal exploration for diagnostic staging
No previous anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and traditional Chinese medicine with clear anti-tumor effects, excluding abdominal exploration for diagnostic staging)
Cannot have received: targeted therapy
Exception: abdominal exploration for diagnostic staging
No previous anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and traditional Chinese medicine with clear anti-tumor effects, excluding abdominal exploration for diagnostic staging)
Cannot have received: immunotherapy
Exception: abdominal exploration for diagnostic staging
No previous anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and traditional Chinese medicine with clear anti-tumor effects, excluding abdominal exploration for diagnostic staging)
Cannot have received: interventional therapy
Exception: abdominal exploration for diagnostic staging
No previous anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and traditional Chinese medicine with clear anti-tumor effects, excluding abdominal exploration for diagnostic staging)
Cannot have received: traditional Chinese medicine with clear anti-tumor effects
Exception: abdominal exploration for diagnostic staging
No previous anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and traditional Chinese medicine with clear anti-tumor effects, excluding abdominal exploration for diagnostic staging)
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, hemoglobin ≥90g/L, platelets ≥100×10^9/L
Kidney function
serum creatinine ≤1.5x ULN, or creatinine clearance ≥50 mL/min (24-hour urine collection if serum creatinine >1.5x ULN)
Liver function
total bilirubin ≤1.5 mg/dL (25.65 μmol/L), AST and ALT ≤2.5x ULN (or 5.0x ULN with liver metastases)
The patient has adequate organs function: hematologic (ANC ≥1.5×10^9/L, hemoglobin ≥90g/L, platelets ≥100×10^9/L), renal (serum creatinine ≤1.5x ULN, or creatinine clearance ≥50 mL/min), hepatic (total bilirubin ≤1.5 mg/dL, AST and ALT ≤2.5x ULN or 5.0x ULN with liver metastases), coagulation (INR ≤1.5)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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