Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT05430035
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05430035
Study Brief:
Protocol Section:
NCT05430035