RecruitingPhase 2NCT06050252

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

A Phase II Trial of Durvalumab With Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma


Sponsor

National Cancer Institute (NCI)

Enrollment

27 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving an immunotherapy drug (durvalumab) together with chemotherapy (gemcitabine and cisplatin) before surgery can shrink liver cancer tumors enough to make surgery more successful. It targets a type of liver cancer called intrahepatic cholangiocarcinoma (cancer of the bile ducts inside the liver). **You may be eligible if...** - You have been diagnosed with intrahepatic cholangiocarcinoma (bile duct cancer inside the liver) that is considered removable by surgery - Your cancer is measurable on a scan - You are considered healthy enough for surgery by a board-certified surgeon - You are 18 or older and in adequate overall health **You may NOT be eligible if...** - Your cancer has already spread beyond the liver and cannot be surgically removed - Your liver, kidney, or heart function is significantly impaired - You have active autoimmune disease or are on long-term steroids - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tissue biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGCisplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT scan

BIOLOGICALDurvalumab

Given IV

DRUGGemcitabine

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI scan

PROCEDUREResection

Undergo surgical resection


Locations(58)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, United States

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, United States

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Memorial Hospital East

Shiloh, Illinois, United States

University of Kansas Clinical Research Center

Fairway, Kansas, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

University of Kansas Cancer Center - Briarcliff

Kansas City, Missouri, United States

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

NYP/Weill Cornell Medical Center

New York, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Smilow Cancer Hospital Care Center - Westerly

Westerly, Rhode Island, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

MD Anderson in The Woodlands

Conroe, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

MD Anderson West Houston

Houston, Texas, United States

MD Anderson League City

League City, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

MD Anderson in Sugar Land

Sugar Land, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06050252


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