A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma
M.D. Anderson Cancer Center
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPembrolizumab
Given by IV (vein)
- DrugGemcitabine
Given by IV (vein)
- DrugCisplatin
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas