RecruitingPhase 2NCT05967182

A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma


Sponsor

M.D. Anderson Cancer Center

Enrollment

24 participants

Start Date

Jan 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of pembrolizumab (an immunotherapy drug) with gemcitabine and cisplatin (chemotherapy) given both before and after surgery for patients with intrahepatic cholangiocarcinoma — a cancer of the bile ducts inside the liver — that may be surgically removable. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of intrahepatic cholangiocarcinoma or biliary adenocarcinoma - Your tumor is potentially resectable (operable) as assessed by a surgeon - Your tumor is measurable by standard imaging criteria (RECIST 1.1) - Your organ function (kidney, liver, blood counts) is adequate for chemotherapy **You may NOT be eligible if...** - Your cancer has spread to distant organs, making curative surgery impossible - You have had prior systemic chemotherapy or immunotherapy for this cancer - You have autoimmune disease or are on immune-suppressing medications - You have serious infections or other conditions that make treatment unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Given by IV (vein)

DRUGGemcitabine

Given by IV (vein)

DRUGCisplatin

Given by IV (vein)


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05967182


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