Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract
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 pri
| Condition(s) | Biliary Tract Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 bett |
| Who can participate | Inclusion Criteria: * The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated well with the follow-up. * At the time of signing the informed consent form, the applicant was over 18 years old and could be of any gender. * Patients with bile duct cancer diagnosed by histological or imaging methods, and whose imaging assessment or clinical assessment indicates borderline resectability * There is at least one measurable lesion (as per the RECIST 1.1 criteria, this measurable lesion must have a spiral CT scan diameter of ≥ 10mm or the short diameter of a swollen lymph node of ≥ 15mm) * Patient has not received any systematic treatment in the past * The patient has locally advanced disease but no distant metastas |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Peking Union Medical College Hospital |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2025-05-25 |
| NCT ID | NCT07267078 |
| Official listing | https://clinicaltrials.gov/study/NCT07267078 |