Gallbladder AdenocarcinomaEarly Phase 1NCT05430035
Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma
A Early Phase 1 study testing HIPEC in people with Gallbladder Adenocarcinoma, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallbladder Adenocarcinoma
- What is being tested?
- HIPEC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to Jul 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
West Virginia University Cancer Institute Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
Brian Boone, MD, 3045984000, brian.boone@hsc.wvu.edu
About this study
Official title: Safety and Feasibility of Prophylactic Heated Intra-peritoneal Chemotherapy (HIPEC) for High-Risk Gallbladder Adenocarcinoma
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
- Gallbladder Adenocarcinoma
- Being tested
- HIPEC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPECDrug
Also called intra-peritoneal chemotherapy, mitomycin c
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°
| Study group | Role | What they receive |
|---|---|---|
| HIPEC | Experimental | 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°. Receives: Drug: HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrences of intraoperative complications
Number of occurrences of intraoperative complications
Measured: During procedure
Occurrences of Postoperative Morbidity and Mortality
Number of occurrences of postoperative morbidity and mortality
Measured: 90 days postoperative
Length of Stay
LOS Median
Measured: Up to 90 days
Readmission
Number of readmission occurrences
Measured: Up to 90 days
Secondary outcomes (2)
Peritoneal Metastases
Incidence of Peritoneal Metastases
Measured: Up to 5 Years
Disease Free Survival
Incidence of Disease Free Survival
Measured: Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start23 Jun 2022
- Primary completionDec 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Boone, MD, FACS, West Virginia University
- Investigators
- Brian Boone, MD, Principal investigator, WVU Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430035
- Sponsor's protocol ID
- 2202522011
- Status last verified
- Apr 2026
- First submitted
- 17 Jun 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Prophylactic Heated Intra-peritoneal Chemotherapy (HIPEC) for High-Risk Gallbladder Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05430035
- Acronym / sponsor ID
- 2202522011
- Conditions
- Gallbladder Adenocarcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC | Experimental | Drug: HIPECProphylactic 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°. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIPECAlso: intra-peritoneal chemotherapy, mitomycin cHeated 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° | Drug | HIPEC |
Primary outcome
Occurrences of intraoperative complications
Time frame: During procedure
Number of occurrences of intraoperative complications
Occurrences of Postoperative Morbidity and Mortality
Time frame: 90 days postoperative
Number of occurrences of postoperative morbidity and mortality
Length of Stay
Time frame: Up to 90 days
LOS Median
Readmission
Time frame: Up to 90 days
Number of readmission occurrences
2 secondary outcomes
Peritoneal Metastases
Time frame: Up to 5 Years
Disease Free Survival
Time frame: Up to 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Boone, MD principal investigator
WVU Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HIPEC in people with Gallbladder Adenocarcinoma, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Boone, MD (3045984000, brian.boone@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrences of intraoperative complications (time frame: During procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.