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A randomized trial of systemic chemotherapy with or without hepatic arterial infusion pump chemotherapy for patients with inoperable bile duct cancer in the liver
EU CTIS ID: 2024-518065-10-00
What this study is testing
Compare the progression-free survival (PFS) of HAI FUDR/Dex in combination with systemic GemOx versus systemic GemOx only.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥18 years
- Platelet count ≥ 75,000/mcL
- Creatinine ≤ 1.8 mg/dL
- Total bilirubin < 1.5 mg/dL
- Hgb > 7 g/dL
- ECOG 0-1
You likely can't join if
- 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
- 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.
- Life expectancy <12 weeks
- Inability to comply with study and/or follow-up procedures.
- History of peripheral neuropathy.
- Patients previously treated with systemic chemotherapy for IHC will be non-eligible.
See the full eligibility criteria
- 1. Age ≥18 years
- Platelet count ≥ 75,000/mcL
- Creatinine ≤ 1.8 mg/dL
- Total bilirubin < 1.5 mg/dL
- Hgb > 7 g/dL
- ECOG 0-1
- 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.
- 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.)
- 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
- Disease must be considered unresectable at the time of preoperative evaluation.
- Considered candidate for general anesthesia, abdominal exploration and hepatic artery pump placement
- Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh class A.
- WBC ≥ 2,000/mcL , ANC ≥ 1000/mcL
- 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
- 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.
- Life expectancy <12 weeks
- Inability to comply with study and/or follow-up procedures.
- History of peripheral neuropathy.
- Patients previously treated with systemic chemotherapy for IHC will be non-eligible.
- Prior treatment with FUDR.
- Prior external beam radiation therapy to the liver.
- Prior ablative therapy to the liver.
- Diagnosis of sclerosing cholangitis
- Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis; surgically related ascites does not exclude the patient).
- Active infection within one week prior to HAI placement.
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.