PhII TrialDurvalumab w/Gemcitabine&CisplatinNeoadj The forHighRisk ResecIntrahepic CholangioCa

UCI Specialty Area: Cancer

Principal Investigator: Zeljka Jutric

Official Title: A Phase II Trial of Durvalumab with Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma

A Study On:

Liver

Study Description

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.

Eligibility

-Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA) that is resectable by imaging evaluation

-Must be at least 18 years of age

-Must have body weight greater than 30 kg

Major surgical procedure within 14 days prior to the first dose of durvalumab

-Patients who are receiving any other investigational agents

-Pregnant women

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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