NCT07639528
Preoperative Durvalumab, Cisplatin, Gemcitabine With or Without Futibatinib Targeted Therapy for the Treatment of Resectable Intrahepatic Cholangiocarcinoma, OPTIC Trial
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentNorthwestern UniversityInvestigator-initiated
~44 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCisplatinComputed TomographyDurvalumabFutibatinibGemcitabine
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Completion of all preoperative testing and therapy
Measured over Up to 3 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Shishir K Maithel, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy
Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
POCBP must have a negative pregnancy test prior to registration on study
Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements
Patients must have the ability to swallow, retain and absorb oral medications
Exclusion
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
Prior anaphylactic reaction to immune checkpoint inhibitors (ICI)
Greater than grade 2 neuropathy
Previous fibroblast growth factor receptor (FGFR) drug use
Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the study drugs
Patients who have an concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including, but not limited to any of the following:
Uncontrolled diabetes
Ongoing or active infection requiring systemic treatment
Symptomatic congestive heart failure
Unstable angina pectoris
Unstable symptomatic arrhythmia
Myocardial infarction within 6 months of enrollment into the study
Serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct
Psychiatric illness/social situations that would limit compliance with study requirements
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
Patients with active other primary malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen (at treating physician's discretion)
Patients who are pregnant or nursing
Patients with active alcohol use or illicit drug use that would, in the opinion of the principal investigator (PI) or a sub investigator (sub-I), prevent the subject from complying with the study protocol and/or endanger the subject during their participation in the study
What this trial measures
- Completion of all preoperative testing and therapyUp to 3 years
Treatment completion is defined as completion of next generation sequencing testing and all preoperative and operative therapy. Will record the completion of all therapy rate, along with the exact 95% binomial confidence interval.
- Incidence of Treatment-Emergent Adverse Events during all preoperative testing and therapyUp to 3 years
Unacceptable toxicity is defined as any grade 3 or higher toxicities by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 that result in a treatment delay of \> 28 days.