HIPEC for Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
West Virginia University Cancer Institute Mary Babb Randolph Cancer Center, Morgantown, WV
Adenocarcinoma+1 More
HIPEC - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 2 Secondary · Reporting Duration: Up to 5 Years

90 days postoperative
Occurrences of Postoperative Morbidity and Mortality
During procedure
Occurrences of intraoperative complications
Up to 5 Years
Disease Free Survival
Peritoneal Metastases
Up to 90 days
Length of Stay
Readmission

Trial Safety

Trial Design

1 Treatment Group

HIPEC
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: HIPEC · No Placebo Group · Phase < 1

HIPEC
Drug
Experimental Group · 1 Intervention: HIPEC · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HIPEC
2014
Completed Phase 3
~220

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: West Virginia University Cancer Institute Mary Babb Randolph Cancer Center · Morgantown, WV
Photo of west virginia 1Photo of west virginia 2Photo of west virginia 3
N/AFirst Recorded Clinical Trial
2 TrialsResearching Adenocarcinoma
0 CompletedClinical Trials

Who is running the clinical trial?

West Virginia UniversityLead Sponsor
153 Previous Clinical Trials
48,366 Total Patients Enrolled
1 Trials studying Adenocarcinoma
40 Patients Enrolled for Adenocarcinoma
Brian Boone, MDPrincipal InvestigatorWVU Cancer Institute
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Adenocarcinoma
40 Patients Enrolled for Adenocarcinoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a hemoglobin level ≥ 10.0 g/dl.
You have an AST (SGOT) of 2.5 or less times the institutional upper limit of normal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.