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Study identifier: NCT05430035 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma

Condition: Gallbladder Adenocarcinoma  ·  Sponsor: West Virginia University

PhaseEARLY_Phase 1
Planned participants10
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Gallbladder adenocarcinoma is a devastating disease associated with a poor prognosis. Gallbladder and other biliary cancers will be responsible for an estimated 11,980 new cases, and 4,090 deaths in the US during 2020. The 5-year survival for all patients with gallbladder cancer is 18%, however this plummets to 2% for patients with metastatic disease. Patients with gallbladder cancer frequently develop peritoneal recurrence, particularly after intra-operative bile spillage during cholecystectomy for incidentally discovered gallbladder malignancy. Once developed, peritoneal metastases are difficult to treat and result in significant morbidity and mortality. As a result, novel approaches that target peritoneal metastases are needed for this disease. Prophylactic use of heated intraperitoneal chemotherapy (HIPEC) has been explored or is under active investigation for numerous gastrointestinal malignancies, including colon, gastric, and appendiceal cancers. HIPEC has efficacy in gallbladder cancer patients with macroscopic peritoneal disease undergoing cytoreductive surgery (CRS)/HIPEC and has been associated with a survival advantage in a multi-institutional retrospective case series. Incidentally discovered gallbladder cancer is treated with central hepatectomy and portal lymphadenectomy, therefore a prophylactic HIPEC can be easily incorporated into the second operation performed as part of the standard of care. In this early phase clinical trial, the investigators will explor…

This description comes directly from the study's public registry record.

Talk to the study team

Brian Boone, MD  ·  3045984000  ·  brian.boone@hsc.wvu.edu

Always discuss trial participation with your own doctor first.

Locations (1)

West Virginia University Cancer Institute Mary Babb Randolph Cancer CenterMorgantown, West Virginia, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05430035