Floxuridine for Intrahepatic cholangiocarcinoma (unresectable)

Inclusion criteria

• {"criterion_text":"- 1. Age ≥18 years\n- Platelet count ≥ 75,000/mcL\n- Creatinine ≤ 1.8 mg/dL\n- Total bilirubin < 1.5 mg/dL\n- Hgb > 7 g/dL\n- ECOG 0-1\n- Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (IHC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be obtained prior XML File Identifier: OlvDuYrPr+P0rcY9vFJaMIbUhz8= Page 23/33 to randomization.\n- Clinical or radiographic evidence of metastatic disease confined to the liver. Note: presence of regional (porta hepatis) lymph node metastases will be allowed, provided they are amenable to resection. (Note: If peritoneal or other extrahepatic disease is found at time of pump placement, the pump will not be implanted. The patient will be removed from study, deemed nonevaluable and will not count toward the overall study accrual.)\n- Radiographically measurable disease. Measurable disease is defined as disease that can be assessed with 2-dimensional measurements on a cross-sectional imaging. Minimum lesion size is 2 cm in greatest diameter as per RECIST criteria\n- Disease must be considered unresectable at the time of preoperative evaluation.\n- Considered candidate for general anesthesia, abdominal exploration and hepatic artery pump placement\n- Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh class A.\n- WBC ≥ 2,000/mcL , ANC ≥ 1000/mcL"}

Exclusion criteria

• {"criterion_text":"- Presence of distant metastatic disease. Patients will undergo radiographic evaluation to exclude the possibility of distant metastatic disease. For patients who have undergone pre- or post-operative biopsies that definitively diagnose IHC, the diagnostic studies may be modified at the discretion of the MSKCC Principal Investigator. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection\n- History of other malignancy within the past 3 years except with early stage/localized cancer that was surgically resected or radiation treatment that would yield the same result as surgery within the past 3 years.\n- Life expectancy <12 weeks\n- Inability to comply with study and/or follow-up procedures.\n- History of peripheral neuropathy.\n- Patients previously treated with systemic chemotherapy for IHC will be non-eligible.\n- Prior treatment with FUDR.\n- Prior external beam radiation therapy to the liver.\n- Prior ablative therapy to the liver.\n- Diagnosis of sclerosing cholangitis\n- Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis; surgically related ascites does not exclude the patient).\n- Active infection within one week prior to HAI placement.\n- Pregnant or lactating women."}

Primary endpoints

• {"endpoint_text":"- Progression-free survival","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 1. Compare the overall survival in first-line HAI FUDR/Dex in combination with GemOx versus systemic GemOx only.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2. Estimate the overall response rate (CR+PR) between treatment groups.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 3. Estimate the time to first recurrence patterns between treatment groups.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 4. Describe the toxicity rates separately for each treatment groups.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Define the mutational pattern of IHC and determine the extent to which genomic features and intratumoral heterogeneity correlate with treatment response and survival.","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

06-11-2024

Latest Decision Or Authorization Date

30-09-2025

Processing Time Days

328

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Memorial Sloan Kettering Cancer Center

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

United States