Testing the Combination of the Anticancer Drug Durvalumab With Chemotherapy (Gemcitabine and Cisplatin) at Improving Outcomes for High-Risk Resectable Liver Cancer Before Surgery

Conditions

• Resectable Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo tissue biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Cisplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Durvalumab — BIOLOGICAL
  Given IV
• Gemcitabine — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI scan
• Resection — PROCEDURE
  Undergo surgical resection

Study Details

This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma.

Key Dates

First listed

Sep 22, 2023

Start date

Jul 10, 2024

Status verified

Sep 2026

Primary completion

Feb 12, 2027

Completion

Feb 12, 2027

Study Design

Enrollment

27 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (durvalumab, gemcitabine, cisplatin)
  Patients receive durvalumab IV over 60 minutes on day 1 with gemcitabine IV over 30 minutes and cisplatin IV over 60 minutes on days 1 and 8 for 4 cycles and then undergo surgical resection on study. Following surgery, patients may continue the durvalumab, gemcitabine and cisplatin regimen for up to 4 additional cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scans and/or MRI scans and blood sample collection throughout study, as well as tissue biopsies during screening and on study.

Primary Outcome Measure

Proportion of patients who complete 4 cycles of neoadjuvant therapy followed by surgical resection [ Time Frame: After surgical resection, up to week 18 after starting neoadjuvant therapy ]

Locations (57)

Find similar trials in Irvine, CA

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