A Phase II study of induction systemic mFOLFIRINOX followed by hepatic arterial infusion of Floxuridine and Dexamethasone given concurrently with systemic mFOLFIRI as a first-line therapy in patients with unresectable liver-dominant intrahepatic cholangiocarcinoma (HELIX-ICC)

Study Name
	A Phase II study of induction systemic mFOLFIRINOX followed by hepatic arterial infusion of Floxuridine and Dexamethasone given concurrently with systemic mFOLFIRI as a first-line therapy in patients with unresectable liver-dominant intrahepatic cholangiocarcinoma (HELIX-ICC)
ClinicalTrials.gov Identifier (if applicable)
	NCT04251715
Clinical Trial Category (check all that apply)
	First Line Therapy
Study Center
Institution Name
	Knight Cancer Institute at Oregon Health & Science University
Institution Address
	3485 SW Bond Ave
City
	Portland
State
	Oregon
Zip Code
	97239
Country
	United States
Website
	https://apps.ohsu.edu/research/study-participation-opportunities-system/knight_viewstudy.php?id=STUDY00016033
List additional Institutions (include address, phone number, and website)
	NA
Study Contacts
Principal Investigator
	Dr. Skye C. Mayo, MD, MPH, FACS, FSSO
P.I. Phone
	(503) 494-5501
P.I. Email
	GIResearch@ohsu.edu
Study Coordinator
	Anna Jackson
Study Coordinator Phone
	503-494- 5165
Study Coordinator Email
	GIResearch@ohsu.edu
OVERVIEW – in layman’s terms (150 words max)
	This clinical trial is for patients with intrahepatic cholangiocarcinoma that is not able to be removed by surgery. This study utilizes the combination of HAI pump therapy and intravenous chemotherapy. The purpose of this study is to test chemotherapy treatment combined with HAI pump therapy to find out how effective it is for patients.
Enrollment
	30, with a 6 patient initial safety-run
Study Start Date
	03/26/2021
Estimated Completion Date
	03/15/2022
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	Seeking to validate our theory that the combination of induction mFOLFIRINOX followed by mFOLFIRI and HAI therapy for intrahepatic cholangiocarcinoma will work well allowing the liver disease to be controlled and in some cases be changed from unresectable to resectable.
Inclusion Criteria – Patients Must:
	Liver-dominant ICC, must comprise <70% of the liver parenchyma, as defined by CT liver segmental volumetrics Disease must be considered technically unresectable or be multifocal in the liver at the time of preoperative evaluation ECOG 0 or 1 status (Karnofsky ≥ 60) WBC ≥ 3000 cells/mm3 ANC ≥ 1500 cells/mm3 Platelet count ≥ 100,000 / mm3 INR ≤ 1.5 Creatinine within normal institutional limits OR creatinine clearance ≥ 60 ml/min/1.73 m2 for participants with creatinine levels above institutional limits Total bilirubin < 1.5 mg/dL AST (SGOT)/ALT(SGPT) ≤ 2.5 x institutional ULN
Exclusion Criteria – Patients Must NOT:
	Presence of extensive or multifocal metastatic extrahepatic or peritoneal disease. Prior treatment with floxuridine, oxaliplatin, or irinotecan Prior external beam radiation therapy to the liver or hepatic arterial or venous delivery of internal radiation therapy such as Y-90. Current biliary obstruction requiring placement of endoscopic or transhepatic stents for biliary decompression Pregnant or lactating women MSI-h or MMR-d
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	Review of medical history Review of any medications you are taking Physical exam Vital signs (blood pressure, heart rate, and temperature), weight, and height Performance status evaluation (what type of daily activities you can do) Electrocardiogram (ECG) Research blood tests—approximately 1 tablespoon or 15 mL Routine blood tests – approximately 2 tablespoons or 29 mL of blood to check your blood counts (numbers of each type of blood cell), chemistries (elements and minerals in your blood), and how well your organs are functioning, and Hepatitis B or C test to determine if you have, or have had, Hepatitis B or C. Pregnancy Test (if needed) If the urine pregnancy test is positive, serum pregnancy tests must be performed Computed Tomography (CT) scan and/or Magnetic Resonance Imaging (MRI) and/or Positronic Emission Tomography (PET) of your tumor Women who can become pregnant must have a negative pregnancy test before a CT or PET scan is performed. Diffuse Weighted‐MRI (DW‐MRI) to help the investigator see the liver tumors and better assess response to treatment CT Angiography (CTA) to examine the structure of blood vessels in your liver to make sure you can receive the HAI pump Laparoscopy to assess your tumor (outpatient procedure that will be done at the same time as the Mediport placement below) Questionnaires and interviews Mediport placement Provide tumor tissue, archival or biopsy Counseling Evaluation to assess support, financial stability, and drug and alcohol use
POTENTIAL SIDE-EFFECTS – in layman’s terms
	Stomach ulcer Bleeding Intestinal upset that may include inflammation of the intestines causing diarrhea, cramps, nausea, vomiting, and fever Inflammation of the tongue Sore throat -inflammation of pharynx and/or tonsils Loss of appetite Cramps Pain in belly Scarring/hardening of the bile duct tissue (biliary sclerosis) Hair loss Yellow of skin called “jaundice” as a result of bile duct scarring Skin rash (dermatitis) Muscle pain or weakness Fatigue Headache Swelling (edema) Confusion or mood changes High blood sugar (hyperglycemia) Weight gain Vision Changes Sleep problems (insomnia) Skin changes (hair growth, acne, slow wound healing, rash)