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Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma

NCT06017297 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-11-12

No results posted yet for this study

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

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

  • AstraZeneca

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Aiwu R He, MD · Georgetown University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06017297 on ClinicalTrials.gov