Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2024

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Borderline Resectable CarcinomaBiliary Tract Cancer
Interventions
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.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Georgetown University

OTHER