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 (Jun 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
Treatments studied
Chemotherapy
Other
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.
Frequently asked questions
Is NCT07165847 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIA or IIB or IIIA or IIIB or IIIC or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages