Preoperative Durvalumab, Cisplatin, Gemcitabine With or Without Futibatinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, OPTIC Trial

Conditions

• Resectable Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood and previously collected tissue sample collection
• Cisplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT
• Durvalumab — BIOLOGICAL
  Given IV
• Futibatinib — DRUG
  Given PO
• Gemcitabine — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI

Study Details

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.

Key Dates

Start date

Dec 10, 2027

Status verified

Jun 2026

Primary completion

Dec 10, 2030

Completion

Dec 10, 2031

Study Design

Enrollment

44 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (durvalumab, cisplatin, gemcitabine, futibatinib)
  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.
• Active Comparator: Arm B (durvalumab, cisplatin, gemcitabine)
  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.

Primary Outcome Measure

Completion of all preoperative testing and therapy [ Time Frame: Up to 3 years ]

Central Contacts

• Study Coordinator
  3126951301
  [email protected]

Locations (1)

Find similar trials in Chicago, IL

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