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Alkylating agents
Pembrolizumab + Chemotherapy for Bile Duct Cancer
Phase 2
Recruiting
Led By Hop Tran Cao, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial will compare adding a drug to standard chemotherapy to standard chemotherapy alone to see if it improves cholangiocarcinoma treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing if adding pembrolizumab (an immunotherapy drug) to the usual chemotherapy drugs gemcitabine and cisplatin before and after surgery can improve outcomes in bile duct cancer compared to just surgery and chemotherapy.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects, including inflammation of organs, fatigue, skin reactions, flu-like symptoms, hormonal changes. Gemcitabine and Cisplatin might cause nausea, kidney damage, low blood cell counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab with Gemcitabine and CisplatinExperimental Treatment3 Interventions
Participants will receive 4 cycles (21 days each) of the combined chemotherapy before and after your scheduled surgery. During the 9 months of chemotherapy treatment, participants will have clinic visits every 3 weeks or so. During the 2-4 year follow-up period, participants will come to the clinic every 3 months or so
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,450 Total Patients Enrolled
Hop Tran Cao, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled illnesses like heart failure or recent heart attacks.I have been treated with drugs targeting immune checkpoints.I have received systemic therapy for bile duct cancer.I have not received a live vaccine in the last 30 days.I do not have any ongoing serious infections requiring treatment.I had radiotherapy less than 2 weeks before starting the study treatment.I have not taken steroids or immunosuppressants in the last 7 days.I have another cancer that is getting worse or was treated in the last 2 years.I have active brain metastases or cancer in the lining of my brain.I have or had lung inflammation that needed steroids.I have received an organ or tissue transplant from another person.I am currently on medication for an infection.My liver and kidney functions are within normal limits.I have both Hepatitis B and C.I don't have any health issues that could affect the study's results.I can communicate in English or another language.I am 18 years old or older.My cancer is a type of bile duct cancer and can be measured by specific criteria.My cancer is high-risk but can be surgically removed and is located in my liver, bile duct, or nearby lymph nodes.I am HIV positive and my HIV is well-controlled with antiretroviral therapy.I am fully active or can carry out light work.My hepatitis B virus load is undetectable with treatment.My cancer is not small cell, neuroendocrine, lymphoma, sarcoma, mixed histology, or mucinous cystic.I have been treated for an autoimmune disease in the last 2 years.I am HIV-positive and have had Kaposi's sarcoma or Multicentric Castleman's Disease.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab with Gemcitabine and Cisplatin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the triad of Pembrolizumab, Gemcitabine and Cisplatin been granted regulatory approval by the FDA?
"The safety of the combination therapy of pembrolizumab with gemcitabine and cisplatin is estimated to be a 2, as this clinical trial falls under Phase 2 standards; meaning that while there are some indications for safety, no efficacy data has been collected."
Answered by AI
Are there any openings currently available in this experiment for participants?
"Clinicaltrials.gov indicates that this research opportunity is not accepting applications at present, as the last edit was made on July 21st 2023. However, 196 other clinical trials are still actively recruiting for patient candidates."
Answered by AI
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