Durvalumab + Chemotherapy for Bile Duct Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot use immunosuppressive medications within 14 days before starting the trial, except for certain types of steroids. It's best to discuss your specific medications with the trial team.
Is the combination of Durvalumab, Gemcitabine, and Cisplatin safe for humans?
The combination of Durvalumab, Gemcitabine, and Cisplatin has been studied in patients with advanced biliary tract cancer, and the safety profile was found to be manageable. This means that while there may be side effects, they are generally considered acceptable and can be managed with medical care.12345
What makes the drug combination of Durvalumab, Cisplatin, and Gemcitabine unique for bile duct cancer?
This drug combination is unique because it includes Durvalumab, an immunotherapy that blocks a protein called PD-L1, helping the immune system fight cancer more effectively. In studies, this combination has shown to significantly improve survival in patients with advanced bile duct cancer compared to the standard chemotherapy alone.12367
What data supports the effectiveness of the drug combination Durvalumab, Gemcitabine, and Cisplatin for bile duct cancer?
Who Is on the Research Team?
Hop Tran Cao, MD
Principal Investigator
University of Texas MD Anderson Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for patients with a specific liver cancer called intrahepatic cholangiocarcinoma that can be surgically removed. They must have measurable disease, no prior treatments for this cancer, and be fit for surgery. The tumor should be larger than 5 cm or there may be regional lymph node metastases or vascular invasion.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Therapy
Participants receive durvalumab with gemcitabine and cisplatin for 4 cycles before surgery
Surgical Resection
Participants undergo surgical resection to remove the tumor
Adjuvant Therapy
Participants may continue durvalumab, gemcitabine, and cisplatin regimen for up to 4 additional cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Durvalumab
- Gemcitabine
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor