NCT06017297

Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma

Phase II Study of Neoadjuvant Durvalumab (MEDI4736) and Tremelimumab in Combination With Gemcitabine and Cisplatin in Patients With Intrahepatic Cholangiocarcinoma That is Borderline Resectable/Resectable But With High Risk for Recurrence.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Borderline Resectable Carcinoma
• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab 1500 mg via intravenous (IV) infusion every 3 weeks for up to 8 cycles
DRUG	Tremelimumab	A single dose of tremelimumab at 300mg IV is given on C1.
DRUG	Gemcitabine	Gemcitabine is dosed at 1000 mg/m2 IV on day (D)1 and D8 of each cycle.
DRUG	Cisplatin	Cisplatin is dosed at 25mg/m2 on D1 and D8 of each cycle.
PROCEDURE	Surgical Resection	If the tumor is evaluated to be resectable (as defined as successfully treated stage II (tumor shrink away from vessels), stage IIIA (tumor shrink away from visceral peritoneum), stage IIIB (N1 disease no longer pathologically enlarged) after C4 or C8, then the patient may proceed with surgical tumor resection.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2023-08-30
• Last updated: 2024-11-12

Regulatory

• FDA-regulated drug study