Preoperative Durvalumab, Cisplatin, Gemcitabine With or Without Futibatinib Targeted Therapy for … (NCT07639528) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Preoperative Durvalumab, Cisplatin, Gemcitabine With or Without Futibatinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, OPTIC Trial
United States44 participantsStarted 2027-12-10
Plain-language summary
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 can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a confirmed biopsy proven diagnosis of resectable intrahepatic cholangiocarcinoma (IHCC) confined to the liver, bile duct, and /or regional lymph nodes confirmed by high-quality cross-sectional imaging by CT or MRI of the chest and MRI of the abdomen, and pelvis performed within 42 days (6 weeks) prior to enrollment. (MRI protocol: With and without gadolineum with T1 and T2 weighted sequences)
* Note: Distant extrahepatic disease is not allowed
* Note: When using CTs in addition to MRI, a high resolution triple phase thin-cut, CT with intravenous +/- oral contrast is the preferred imaging technique for assessing radiographic tumor response
* Patients must have measurable disease per RECIST 1.1
* Patients must be treatment naïve
* Patients must be age ≥ 18 years
* Patient with CORE biopsy for diagnosis that is sufficient enough to do NGS
* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* 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)
* Serum total bilirubin ≤ 2 X Institutional upper limit of normal (ULN)
* For Gilbert's disease: these value does not apply and treatment will be done per treating physician
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) ≤ 5 x institutional ULN
* For Gilbert's disease: these value does not apply and treatment will b…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing durvalumab plus cisplatin and gemcitabine, with or without an additional targeted drug called futibatinib, before surgery — can you help me understand why this combination is being studied specifically for my type of bile duct cancer, and whether my tumor would need to be tested for anything, like an FGFR2 alteration, to be eligible for the arm that includes futibatinib?
2Since this is a Phase 2 trial and it's not yet recruiting, the main things being measured are whether patients can actually complete all the pre-surgery treatment and what kinds of side effects come up — what does that tell us about how much is still unknown about safety and benefit, and how does that compare to standard treatment options I might have right now?
3Receiving chemotherapy, immunotherapy, and possibly a targeted drug all before surgery sounds intensive — what would the treatment schedule actually look like week to week, and is that something that would be realistic given my current health and life situation?
4Because this trial isn't recruiting yet, there could be a gap before I could even enroll — given that my cancer is currently considered resectable, is waiting potentially risky, and what would happen to my surgical options if anything changed during that time?
5If I were to discuss this trial with you and ultimately decide it's not the right fit for me, what are the standard preoperative or surgical approaches for resectable intrahepatic cholangiocarcinoma that we should be considering as an alternative?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Completion of all preoperative testing and therapy
Timeframe: Up to 3 years
2
Incidence of Treatment-Emergent Adverse Events during all preoperative testing and therapy