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

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

Trial Details

NCT ID
NCT06050252
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Cisplatin
  • Computed Tomography
  • Durvalumab
  • Gemcitabine
Locations (sample)
  • Irvine, California, United States|33.66946,-117.82311
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Derby, Connecticut, United States|41.32065,-73.089
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Gainesville, Florida, United States|29.65163,-82.32483

Key Eligibility Criteria

  • Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA) that is resectable by imaging evaluation. Choic…
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter t…
  • Patients must be an acceptable risk surgical candidate at the time of enrollment, as determined by a board-certified surgeon with expertise in hepa…
  • High-risk iCCA is defined as the presence of any of these factors:

For full eligibility, visit ClinicalTrials.gov.

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