Study on Pembrolizumab with Gemcitabine and Cisplatin for Treating Resectable Intrahepatic Cholangiocarcinoma
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05967182
This clinical trial is exploring whether adding the drug pembrolizumab to standard chemotherapy (gemcitabine and cisplatin) before surgery can improve long-term outcomes for patients with intrahepatic cholangiocarcinoma, a type of liver cancer.
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Program Overview
The aim of this study is to determine if combining pembrolizumab with standard chemotherapy drugs, gemcitabine and cisplatin, before surgery can enhance the long-term response in patients with intrahepatic cholangiocarcinoma. Researchers want to see if this combination can help prevent the cancer from returning after surgery, compared to using surgery and standard chemotherapy alone.
Description
This study focuses on evaluating the effectiveness and safety of adding pembrolizumab to standard chemotherapy for patients with potentially resectable intrahepatic cholangiocarcinoma. The primary goals are to measure how long patients remain free of cancer after surgery and to assess the extent of cancer cell reduction in tumors. Secondary goals include evaluating the safety of the treatment and overall survival rates.
Researchers will also explore how the treatment affects the immune system and other biological markers, including the diversity of gut and biliary microbiomes, and the presence of certain genetic markers in blood and tissue samples. Participants will undergo various tests and procedures to monitor their health and the treatment's impact.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of intrahepatic cholangiocarcinoma or a similar type of cancer that can be measured by scans.
- Cancer must be high-risk but still removable by surgery, confined to the liver, bile duct, or nearby lymph nodes.
- Must have good overall health with a performance status of 0 or 1.
- Adequate blood cell counts and organ function, including liver and kidney function.
- For those with hepatitis B or C, the infection must be under control with undetectable viral load.
- Must agree to use effective birth control during the study and for a period after treatment.
- Must be willing to sign an informed consent document and comply with study requirements.
- HIV-positive participants must have well-controlled HIV with stable treatment.
Exclusion Criteria
- Previous treatment with pembrolizumab or similar drugs.
- Prior systemic therapy for intrahepatic cholangiocarcinoma.
- Have other types of cancer or mixed tumor types.
- Recent heart problems or uncontrolled infections.
- Recent radiation therapy or live vaccines.
- Currently in another clinical trial or using investigational drugs.
- Active autoimmune diseases requiring treatment.
- Active infections or uncontrolled hepatitis B or C.
- Pregnant or breastfeeding women.
- History of organ transplant or cognitive impairment.
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