Using heated chemotherapy to treat high-risk gallbladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and feasibility of heated intraperitoneal chemotherapy (HIPEC) for patients with high-risk gallbladder adenocarcinoma. The study focuses on individuals who have experienced bile spillage during surgery or have advanced tumor characteristics. By administering HIPEC, the trial aims to target peritoneal metastases, which are often difficult to treat and lead to poor outcomes. The study is conducted at the West Virginia University Cancer Institute, where eligible patients will receive this novel treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects must have histologically or cytologically confirmed gallbladder adenocarcinoma AND inadvertent spillage of bile or intentional decompression during cholecystectomy OR tumors extending through the serosa of the gallbladder (T3/T4) OR poorly differentiated gallbladder adenocarcinoma.
* ECOG Performance status ≤ 2
* Subjects must have normal organ and marrow function as defined below:

  * Hemoglobin ≥ 10.0 g/dl
  * Leukocytes ≥ 3,000/mcL
  * Absolute neutrophil count ≥ 1,500/mcL
  * Platelet count ≥ 100,000/mcL
  * Total bilirubin within normal institutional limits
  * AST (SGOT) ≤ 2.5 X institutional upper limit of normal
  * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
  * Serum Creatinine within normal institutional limits
* Eligible TNM staging includes \>T1b meeting above criteria, any N, and M0
* Eligible candidates for standard surgical management which includes central liver resection (+ cholecystectomy if not already performed) and portal lymphadenectomy
* Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Prior systemic therapy for gallbladder adenocarcinoma
* Subjects receiving any other investigational agents.
* Subjects with known or suspected metastatic disease
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to MMC or other agents used in this study.
* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or breastfeeding are excluded from this study because MMC has the potential for teratogenic or abortifacient effects. Because there is known risk for adverse events in nursing infants secondary to treatment of the mother with MMC, breastfeeding should be discontinued if the mother is treated with MMC.
* Subjects with past medical history of hepatitis B or C
* Subjects with evidence of biliary obstruction thought to be cancer related, including subjects requiring biliary stent

Where it's running

• West Virginia University Cancer Institute Mary Babb Randolph Cancer Center
  Morgantown, West Virginia, United States Recruiting

Study contacts

• Principal investigator: Brian Boone, MD — WVU Cancer Institute
• Study coordinator: Brian Boone, MD
• Email: brian.boone@hsc.wvu.edu
• Phone: 3045984000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.