OncoMatch/Clinical Trials/NCT07267078
Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract Cancer
Is NCT07267078 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT07267078 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.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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