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

Starting soon · Phase 2

Conditions studied: Resectable Intrahepatic Cholangiocarcinoma

In brief

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 facts

Study ID: NCT07639528
Run by: Northwestern University
People needed: 44
Starts: 2027-12-10
Expected to finish: 2031-12-10
Last updated by the study team: 2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 be done per treating physician
Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) ≤ 5 x institutional ULN
For Gilbert's disease: these value does not apply and treatment will be done per treating physician
Creatinine ≤ 1.5 X Institutional ULN
Calcium-phosphorus product < 55 mg\^2 /dL2 (5.5mg/dL)
Total corrected serum calcium within local normal limits
Inorganic phosphorus within local normal limits
For patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration. Please note this lab is not a requirement for eligibility, however, if it has been completed previously as part of the patient's health care, it should be documented for eligibility
For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with a known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Please note this lab is not a requirement for eligibility, however if it has been completed previously as part of the patient's health care, it should be documented for eligibility
The futibatinib and other therapeutic agents used in this trial are known to be teratogenic. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 11 and 14 months for POCBP and men respectively, following completion of study drug therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from 28 days prior to starting gemcitabine/cisplatin/durvalumab (including dose interruptions) for the duration of study participation, and 11 and 14 months for POCBP and men respectively, months after completion of study drug administration.
Male subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine/cisplatin/durvalumab and for 14 months following, even if he has undergone a successful vasectomy.

You may not qualify if…

Patients with peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. In CTCAE version 5.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)
Patients who are receiving any other investigational agents
Patients who have current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, inflammation or ulceration, keratoconjunctivitis, confirmed by ophthalmic examination
Note: Patients with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study
Patients who have used medications known to prolong the QT interval and/or are associated with a risk of Torsades de Pointes (TdP) 7 days prior to first dose of study drug
Patients who have clinically significant cardiac disease including any of the following: Congestive heart failure requiring treatment (New York Heart Association grade ≥ 2), or uncontrolled hypertension (refer to the European Society of Cardiology and European Society of Hypertension guidelines (Williams et al 2018)
Patients with corrected QT interval using Fridericia formula (QTcF) > 470 msec (males and females)
Note: If the QTcF is > 470 msec in the first electrocardiogram (ECG), a total of 3 ECGs separated by at least 5 minutes should be performed. If the average of these 3 consecutive results for QTcF is ≤ 470 msec, the patient meets eligibility in this regard
Patient with known history of congenital long QT syndrome
Patients who have current evidence of concerning endocrine alterations of calcium/phosphate homeostasis, eg, parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc., in the opinion of the investigator OR and taking medications which increase serum phosphorus and/or calcium concentration
Patients who have abnormal calcium or phosphorus, or calcium-phosphorus product ≥ 55 mg\^2 /dL2:
Inorganic phosphorus above local normal limits
Total corrected serum calcium above local normal limits
Patients who are currently receiving or are planning to receive during participation in this study, treatment with agents that are known strong inducers or inhibitors of CYP3A4
Note: Patients are not permitted to receive enzyme-inducing anti-epileptic drugs
Patients with known central nervous system (CNS) disease, except for treated brain metastasis. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded.
Note: Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (radiosurgery [RS]; gamma knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician
Patients who have the following would be excluded (as they would be contraindicated from receiving the trial drugs)
Patients with history of ototoxicity or hearing issues (contraindicated for cisplatin administration)
Patients with the following should not receive immunotherapy
History or active autoimmune disease
Previous immunotherapy use
Require immunosuppressive medications greater than 10mg of prednisone
History of pneumonitis or interstitial lung disease
History of grade ≥ 2 myocarditis

Where it is running

Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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