Durvalumab + Chemotherapy for Liver Cancer

SC
Overseen ByStudy Coordinator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

SK

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

* Absolute neutrophil count (ANC) ≥ 1,000/mcL
* Hemoglobin (Hgb) ≥ 8 g/dL (blood transfusion allowed up to 7 days prior to starting on study drug)
I have biopsy-confirmed IHCC that can be removed by surgery and is limited to my liver area.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive durvalumab, cisplatin, and gemcitabine while awaiting NGS results. Patients with FGFR2 mutations also receive futibatinib.

Up to 9 weeks
Multiple visits for IV administration and monitoring

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.

Every 3 months for 3 years

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

Group I: Arm A (durvalumab, cisplatin, gemcitabine, futibatinib)Experimental Treatment7 Interventions
Group II: Arm B (durvalumab, cisplatin, gemcitabine)Active Control6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+