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

Phase II, Open Label, Non-Randomized, Study of Optimal Preoperative Therapy for Intrahepatic Cholangiocarcinoma (OPTIC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Resectable Intrahepatic Cholangiocarcinoma
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging; Drug: Cisplatin; Drug: Gemcitabine; Procedure: Computed Tomography; Biological: Durvalumab; Drug: Futibatinib; Procedure: Biospecimen Collection

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the feasibility and safety of a novel treatment strategy that includes conducting next generation sequencing (NGS) on a preoperative tissue biopsy to administer prior to surgical resection.

SECONDARY OBJECTIVES:

I. To assess the radiological response rate (RRR) according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and advanced image analysis (radiomics) in patients with resectable intrahepatic cholangiocarcinoma (IHCC).

II. To assess the degree of pathologic response in the surgical specimen of patients with resectable intrahepatic cholangiocarcinoma (IHCC).

III. To assess response by measuring circulating tumor DNA (CT-DNA) dynamics in the blood samples of patients with resectable intrahepatic cholangiocarcinoma (IHCC).

IV. To determine the R0 resection rate post-surgery in patients with resectable intrahepatic cholangiocarcinoma (IHCC).

V. To determine progression-free survival (PFS) in patients with resectable intrahepatic cholangiocarcinoma (IHCC).

VI. To determine recurrence-free survival (RFS) in patients with resectable intrahepatic cholangiocarcinoma (IHCC).

VII. To identify patients' overall survival (OS) rate in patients with resectable intrahepatic cholangiocarcinoma (IHCC).

EXPLORATORY OBJECTIVE:

I. To assess the circulating and tumor immune microenvironment in tissue and blood samples.

OUTLINE:

Patients receive durvalumab intravenously (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.

After obtaining NGS molecular results, patients with FGFR2 fusion, rearrangement, or activating mutation are assigned to Arm A, while patients without FGFR2 fusion, rearrangement, or activating mutation are assigned to Arm B.

ARM A: Patients receive futibatinib orally (PO) once daily (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 magnetic resonance imaging (MRI), computed tomography (CT) and blood sample collection throughout the trial.

ARM B: 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.

After completion of study treatment, patients are followed up every 3 months for 3 years.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 3126951301; Email: cancertrials@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
      • Principal Investigator: Shishir K. Maithel, MD
      • Contact: Shishir K. Maithel, MD; Phone Number: 404-617-7936; Email: Shishir.maithel@nm.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Magnetic Resonance Imaging (MRI); sMRI; Magnetic resonance imaging (procedure); MRIs; Structural MRI; Drug: Cisplatin; Given IV; Other Names: CDDP; Cis-diamminedichloridoplatinum; Cismaplat; Cisplatinum; Neoplatin; Platinol; Abiplatin; Blastolem; Briplatin; Cis-diammine-dichloroplatinum; Cis-diamminedichloro Platinum (II); Cis-diamminedichloroplatinum; Cis-dichloroammine Platinum (II); Cis-platinous Diamine Dichloride; Cis-platinum; Cis-platinum II; Cis-platinum II Diamine Dichloride; Cisplatina; Cisplatyl; Citoplatino; Citosin; Cysplatyna; DDP; Lederplatin; Metaplatin; Peyrone's Chloride; Peyrone's Salt; Placis; Plastistil; Platamine; Platiblastin; Platiblastin-S; Platinex; Platinol- AQ; Platinol-AQ; Platinol-AQ VHA Plus; Platinoxan; Platinum; Platinum Diamminodichloride; Platiran; Platistin; Platosin; Drug: Gemcitabine; Given IV; Other Names: dFdCyd; dFdC; Difluorodeoxycytidine; Procedure: Computed Tomography; Undergo CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Computerized axial tomography (procedure); Computerized Tomography (CT) scan; Diagnostic CAT Scan; Diagnostic CAT Scan Service Type; Biological: Durvalumab; Given IV; Other Names: Imfinzi; Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer; MEDI-4736; MEDI4736; MEDI 4736; Drug: Futibatinib; Given PO; Other Names: TAS-120; Lytgobi; TAS120; TAS 120; Procedure: Biospecimen Collection; Undergo blood and previously collected tissue sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection
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.	Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Magnetic Resonance Imaging (MRI); sMRI; Magnetic resonance imaging (procedure); MRIs; Structural MRI; Drug: Cisplatin; Given IV; Other Names: CDDP; Cis-diamminedichloridoplatinum; Cismaplat; Cisplatinum; Neoplatin; Platinol; Abiplatin; Blastolem; Briplatin; Cis-diammine-dichloroplatinum; Cis-diamminedichloro Platinum (II); Cis-diamminedichloroplatinum; Cis-dichloroammine Platinum (II); Cis-platinous Diamine Dichloride; Cis-platinum; Cis-platinum II; Cis-platinum II Diamine Dichloride; Cisplatina; Cisplatyl; Citoplatino; Citosin; Cysplatyna; DDP; Lederplatin; Metaplatin; Peyrone's Chloride; Peyrone's Salt; Placis; Plastistil; Platamine; Platiblastin; Platiblastin-S; Platinex; Platinol- AQ; Platinol-AQ; Platinol-AQ VHA Plus; Platinoxan; Platinum; Platinum Diamminodichloride; Platiran; Platistin; Platosin; Drug: Gemcitabine; Given IV; Other Names: dFdCyd; dFdC; Difluorodeoxycytidine; Procedure: Computed Tomography; Undergo CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Computerized axial tomography (procedure); Computerized Tomography (CT) scan; Diagnostic CAT Scan; Diagnostic CAT Scan Service Type; Biological: Durvalumab; Given IV; Other Names: Imfinzi; Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer; MEDI-4736; MEDI4736; MEDI 4736; Procedure: Biospecimen Collection; Undergo blood and previously collected tissue sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of all preoperative testing and therapy	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.	Up to 3 years
Incidence of Treatment-Emergent Adverse Events during all preoperative testing and therapy	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.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological response rate	Will be assessed by according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and defined as the percentage of patients who will have complete response, partial response or stable disease after the neoadjuvant therapy.	Up to 3 years
Pathologic response rate (PRR)	Will be defined as the degree of treatment effect to preoperative therapy. Pathologic complete response (pCR) will be defined as no viable tumor cells (0% viable tumor, 100% necrosis or fibrosis). Absent response will be defined as 100% viable tumor cells with no evidence of tumor regression. Partial response will be defined as degree of necrosis or fibrosis in the tumor bed, rounded to the nearest 10% interval. This is an endpoint to assess the pathologic response to futibatinib in those with FGFR2 fusions / rearrangements / activating mutations compared to cytotoxic chemotherapy in those without FGFR2 fusions/alterations. Pathological response will be measured by a three-tier response rate using pathologic (p) complete response = 0% tumor cells, no response = no histologic evidence of tumor regression and partial response = % necrosis and evident tumor regression. PRR will be calculated by Northwestern's pathologists with subspecialty training in gastrointestinal pathology.	At the time of surgery
Response by measuring circulating tumor deoxyribonucleic acid in the blood samples of patients with resectable intrahepatic cholangiocarcinoma		Up to 3 years
R0 resection rate		Up to 7 days after last dose of study drug
Progression-free survival (PFS)	Disease progression is defined as progressive disease per RECIST 1.1, other documented clinical or radiographical progression per physician judgement, or death due to disease. If disease progression or death from any cause is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the PFS will be censored as the last available disease assessment.	From the time of enrollment to either the day of first documented disease progression or death from any cause, assessed up to 3 years
Recurrence-free survival (RFS)	Disease recurrence is defined as documented clinical or radiographical progression per physician judgment, or death due to disease. Disease progression/recurrence, if it occurs, will be noted by the treating clinician. RFS data will be collected from baseline (day of surgery) until the subject experiences disease recurrence, initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause, whichever comes first.	Time that elapses between time of surgery and either the day of first documented disease recurrence or death from any cause, assessed up to 3 years
Overall survival		From enrollment to the date of any cause death from or to the date of last follow-up if patients are alive, assessed up to 3 years

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Shishir K Maithel, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2027
• Primary Completion (Estimated): December 10, 2030
• Study Completion (Estimated): December 10, 2031

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Elements; Metals; Chemistry Techniques, Analytical; Spectrum Analysis; Metals, Heavy; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Hydrogen Sulfide; Platinum Compounds; Transition Elements; Gemcitabine; Immunoglobulin G; Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Specimen Handling; Magnetic Resonance Spectroscopy; durvalumab; Disulfides; Platinum; futibatinib
• Other Study ID Numbers: NU 25I12 (Other Identifier: Northwestern University); P30CA060553 (U.S. NIH Grant/Contract); NCI-2026-03371 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); STU00226069

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No