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.