Actively Recruiting
Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma
Led by West Virginia University · Updated on 2026-04-20
10
Participants Needed
1
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 explore the safety and feasibility of prophylactic HIPEC for gallbladder cancer in patients at high-risk of peritoneal recurrence. The primary endpoint is to assess feasibility of the prophylactic heated intraperitoneal chemotherapy (HIPEC) approach in gallbladder cancer. The primary endpoints include occurrence of intra-operative complications, technical challenges, 90-day postoperative morbidity and mortality, length of stay and readmission, which will be documented and compared with historical controls after follow-up.
CONDITIONS
Official Title
Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed gallbladder adenocarcinoma with either bile spillage or decompression during gallbladder surgery, tumors extending through gallbladder outer layer (T3/T4), or poorly differentiated cancer
- ECOG performance status 2 or less
- Normal organ and marrow function with hemoglobin ≥ 10.0 g/dl, leukocytes ≥ 3,000/mcL, neutrophils ≥ 1,500/mcL, platelets ≥ 100,000/mcL, normal bilirubin, AST and ALT ≤ 2.5 times normal, and normal creatinine
- Cancer stage greater than T1b, any lymph node status, and no distant metastasis (M0)
- Eligible for standard surgery including central liver resection and portal lymphadenectomy
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Prior systemic therapy for gallbladder adenocarcinoma
- Receiving any other investigational treatments
- Known or suspected metastatic disease
- Allergic reactions to mitomycin C or similar agents
- Uncontrolled illnesses such as infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
- Pregnant or breastfeeding women
- History of hepatitis B or C
- Biliary obstruction related to cancer including need for biliary stent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West Virginia University Cancer Institute Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
B
Brian Boone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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