Durvalumab + Chemotherapy for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial tests the safety and effectiveness of preoperative immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine with or without futibatinib targeted therapy in treating patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine and/or targeted therapy with futibatinib before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. Patients whose molecular profiling test result show a genetic change called FGFR2 fusion, rearrangement, or activating mutation, receive immunotherapy, chemotherapy and targeted therapy while patients without a FGFR2 fusion, rearrangement, or activating mutation just receive immunotherapy and chemotherapy. Giving targeted therapy based on molecular profile test results prior to attempted resection for patients with intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes in patients with resectable intrahepatic cholangiocarcinoma.
Who Is on the Research Team?
Shishir K Maithel, MD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
This trial is for adults (18+) with a confirmed diagnosis of intrahepatic cholangiocarcinoma (a type of liver cancer) that can be removed by surgery and has not spread outside the liver area. Participants must not have had prior treatment for this cancer, need to be in good physical condition, and have adequate blood counts.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Treatment
Participants receive durvalumab, cisplatin, and gemcitabine while awaiting NGS results. Patients with FGFR2 mutations also receive futibatinib.
Surgery
Surgical resection of the tumor is performed after completion of preoperative therapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including progression-free survival and recurrence-free survival assessments.
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Durvalumab
- Futibatinib
- Gemcitabine
Trial Overview
The study tests if giving immunotherapy (durvalumab) plus chemotherapy (cisplatin and gemcitabine), with or without targeted therapy (futibatinib), before surgery helps shrink tumors in resectable intrahepatic cholangiocarcinoma. Futibatinib is only given to patients whose tumor has certain genetic changes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients receive durvalumab IV over 60 minutes on day 1 and cisplatin IV over 60 minutes and gemcitabine IV over 30 minutes on days 1 and 8 of one 21-day cycle in the absence of disease progression or unacceptable toxicity while awaiting for NGS results. Patients receive futibatinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, CT and blood sample collection throughout the trial.
Patients receive durvalumab IV over 60 minutes on day 1 and cisplatin IV over 60 minutes and gemcitabine IV over 30 minutes on days 1 and 8 of one 21-day cycle in the absence of disease progression or unacceptable toxicity while awaiting for NGS results. Patients continue receiving durvalumab IV over 60 minutes on day 1 and cisplatin IV over 60 minutes and gemcitabine IV over 30 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, CT and blood sample collection throughout the trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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