Pembrolizumab + Chemotherapy for Bile Duct Cancer
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain treatments like systemic steroids or immunosuppressive therapy, you may need to adjust them before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination of Pembrolizumab, Gemcitabine, and Cisplatin for bile duct cancer?
Is the combination of Pembrolizumab, Gemcitabine, and Cisplatin safe for treating bile duct cancer?
What makes the drug pembrolizumab combined with chemotherapy unique for bile duct cancer?
Research Team
Hop Tran Cao, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
Adults diagnosed with intrahepatic cholangiocarcinoma that can potentially be removed by surgery. They should not have had previous systemic therapy for this cancer, no other active cancers or serious illnesses, and must agree to use contraception. HIV-positive patients on effective treatment can join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab with gemcitabine and cisplatin for 4 cycles (21 days each) before and after surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cisplatin
- Gemcitabine
- Pembrolizumab
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor