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Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma

Primary Purpose

Gallbladder Adenocarcinoma

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

HIPEC

About this trial

This is an interventional treatment trial for Gallbladder Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

West Virginia University Cancer Institute Mary Babb Randolph Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIPEC

Arm Description

Prophylactic Heated Intra-peritoneal Chemotherapy (HIPEC) 30 mg of mitomycin C (MMC) over the first 60 minutes followed by 10 mg over an additional 30 minutes. Perfusate will be heated to obtain a tissue temperature of 42°.

Outcomes

Primary Outcome Measures

Occurrences of intraoperative complications

Number of occurrences of intraoperative complications

Occurrences of Postoperative Morbidity and Mortality

Number of occurrences of postoperative morbidity and mortality

Length of Stay

LOS Median

Readmission

Number of readmission occurrences

Secondary Outcome Measures

Peritoneal Metastases

Incidence of Peritoneal Metastases

Disease Free Survival

Incidence of Disease Free Survival

Full Information

NCT ID

NCT05430035

First Posted

June 17, 2022

Last Updated

October 24, 2022

Sponsor

West Virginia University

1. Study Identification

Unique Protocol Identification Number

NCT05430035

Brief Title

Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma

Official Title

Safety and Feasibility of Prophylactic Heated Intra-peritoneal Chemotherapy (HIPEC) for High-Risk Gallbladder Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 23, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gallbladder Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIPEC

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

HIPEC

Intervention Description

Heated Intra-Peritoneal Chemotherapy (HIPEC) HIPEC will be performed at the time of the index operation if a cancer is known pre-operatively, at the time of re-operation for incidentally discovered cancers already treated with cholecystectomy that are undergoing central hepatectomy and portal lymphadenectomy as part of standard of care, or independently if no other procedures are indicated. A closed technique will be utilized to deliver mitomycin C (MMC) over the first 60 minutes followed by an additional smaller dose over an additional 30 minutes. Perfusate will be heated to obtain a tissue temperature of 42°

Primary Outcome Measure Information:

Title

Occurrences of intraoperative complications

Description

Number of occurrences of intraoperative complications

Time Frame

During procedure

Title

Occurrences of Postoperative Morbidity and Mortality

Description

Number of occurrences of postoperative morbidity and mortality

Time Frame

90 days postoperative

Title

Length of Stay

Description

LOS Median

Time Frame

Up to 90 days

Title

Readmission

Description

Number of readmission occurrences

Time Frame

Up to 90 days

Secondary Outcome Measure Information:

Title

Peritoneal Metastases

Description

Incidence of Peritoneal Metastases

Time Frame

Up to 5 Years

Title

Disease Free Survival

Description

Incidence of Disease Free Survival

Time Frame

Up to 5 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brian Boone, MD

Phone

3045984000

brian.boone@hsc.wvu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Boone, MD

Organizational Affiliation

WVU Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

West Virginia University Cancer Institute Mary Babb Randolph Cancer Center

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brian Boone, MD

Phone

304-598-4000

brian.boone@hsc.wvu.edu

12. IPD Sharing Statement

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Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma

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