Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma
Status:
Recruiting
Trial end date:
2026-11-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to test feasibility and safety of the combination of
tremelimumab and durvalumab plus gemcitabine and cisplatin as a neoadjuvant treatment bridge
patients to a curative resection in treatment naïve borderline resectable, or resectable with
high risk for recurrence intrahepatic cholangiocarcinoma patients. The main question[s] it
aims to answer are:
- What is the rate of conversion of unresectable tumor to resectable cancer?
- What are the side effects of this treatment combination?
Participants will undergo an initial tumor biopsy, imaging and laboratory studies prior to
starting treatment with durvalumab, tremelimumab, gemcitabine and cisplatin. Participants
will continue for 4 cycles and if the tumor is found to be resectable then they will undergo
surgical resection. If the tumor is unresectable (can't be surgically removed) after 4
cycles, then participants will receive 4 more cycles and repeated imaging. If the tumor
remains unresectable then the participant will be treated with capecitabine for up to 8
cycles and durvalumab for up to 12 months.