Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma

Sponsor
Georgetown University
Study ID
NCT06017297
Phase
PHASE2
Status
Withdrawn

Conditions

  • Biliary Tract Cancer
  • Borderline Resectable Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500 mg via intravenous (IV) infusion every 3 weeks for up to 8 cycles
  • Tremelimumab — DRUG
    A single dose of tremelimumab at 300mg IV is given on C1.
  • Gemcitabine — DRUG
    Gemcitabine is dosed at 1000 mg/m2 IV on day (D)1 and D8 of each cycle.
  • Cisplatin — DRUG
    Cisplatin is dosed at 25mg/m2 on D1 and D8 of each cycle.
  • Surgical Resection — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Dec 31, 2024
Status verified
Nov 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab and Tremelimumab plus gemcitabine/cisplatin
    Durvalumab and tremelimumab plus gemcitabine/cisplatin combination therapy. If the tumor is evaluated to be resectable after Cycle 4 (C4), then the patient may proceed with surgical tumor resection. If the tumor is deemed unresectable after C4, then the patient will proceed with Cycle 5-8 followed by reevaluation for surgical resection.

Primary Outcome Measure

Rate of Conversion from unresectable to resectable [ Time Frame: 8 Cycles, 21 day cycles ]

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