M.D. Anderson Cancer Center
To find out if adding pembrolizumab to standard of care chemotherapy drugs (cisplatin and gemcitabine) will improve long-term response of intrahepatic cholangiocarcinoma after surgery, compared to treatment with surgery and standard chemotherapy alone.
Primary Objectives and Endpoints: * To evaluate RFS. RFS will be defined as time from curative-intent surgery to disease recurrence. Median, 9-month, and 12-month RFS rates will be measured. * To evaluate the rate of major pathologic response. Pathologic response will be assessed both by determining the percentage of the bulk tumor made up of viable cancer cells, with \< 10% signifying a major pathologic response, and by evaluating indicators of immune-mediated pathologic response which incorporate elements of tumor necrosis and fibroinflammatory stroma. Primary Endpoints: RFS rate, major pa…
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Provision of signed Informed Consent prior to any screening procedures being performed. 2. Age ≥ 18 years at the time of informed consent. 3. Histologically (or cytologically) confirmed diagnosis of intrahepatic cholangiocarcinoma or adenocarcinoma of suspected biliary origin/ cholangiocarcinoma that is measurable according to RECIST 1.1 criteria. a) Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such…
Given by IV (vein)
Given by IV (vein)
Given by IV (vein)
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