OncoMatch/Clinical Trials/NCT07267078
Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract Cancer
Is NCT07267078 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy for biliary tract cancer.
Treatment: Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy — The goal of this clinical trial is to learn if Tuvonralimab/Iparomlimab-based neoadjuvant regimens can improve surgical and pathological outcomes in adults (≥18 years) with resectable or borderline-resectable biliary tract cancer (intrahepatic/extrahepatic cholangiocarcinoma or gallbladder cancer), ECOG 0-1, and no prior neoadjuvant therapy. The main questions it aims to answer are: 1. Does the regimen increase the R0 resection rate (negative margins)? 2. Does it raise major or pathologic complete response rates (MPR/pCR) and improve event-free survival (EFS) without increasing perioperative complications? Researchers will compare Tuvonralimab/Iparomlimab-based therapy + GEMOX chemotherapy to surgery to see if immunotherapy leads to higher R0 resection, deeper pathologic response, and better EFS/PFS/OS with acceptable safety. Participants will: Undergo baseline assessments: imaging (contrast-enhanced CT/MRI ± PET), labs, histology, and optional biomarker sampling. Receive neoadjuvant therapy: 2-4 cycles (\\\~6-12 weeks) of a Tuvonralimab/Iparomlimab-based regimen per protocol. Have restaging by RECIST 1.1; eligible participants proceed to curative-intent surgery with central review of margins and tumor regression grading (TRG/MPR/pCR). Receive protocol-directed postoperative management and safety monitoring (CTCAE v5.0) and be followed every 8-12 weeks for EFS, PFS, OS, conversion-to-resection rate, nodal down-staging, perioperative complications, length of stay, and any surgery delays.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Hb ≥ 90 g/L; Neutrophils ≥ 1.5 × 10^9/L; PLT ≥ 100 × 10^9/L; no blood transfusion, no use of G-CSF, no use of drugs for correction within 14 days before screening
Kidney function
Creatinine ≤ 1.5 × ULN, or creatinine clearance rate (CCr) > 50 mL/min (Cockcroft-Gault); no albumin transfusion within 14 days
Liver function
ALT and AST ≤ 2.5 × ULN; Bilirubin ≤ 2.0 × ULN; no albumin transfusion within 14 days
Cardiac function
No significant clinical cardiovascular and cerebrovascular diseases, including but not limited to acute myocardial infarction within 6 months, severe/unstable angina, cerebrovascular accident or TIA, congestive heart failure (NYHA ≥ 2), arrhythmias requiring anti-arrhythmic drugs (except beta-blockers or digoxin), repeated ECG QTc > 480 ms
The hematology and organ functions are adequate... see inclusion and exclusion criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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