A Randomized Phase II Study of Systemic Chemotherapy with or without HAI FUDR/Dexamethasone in Patients with Unresectable Intrahepatic Cholangiocarcinoma

Phase 2

• Conditions: Unresectable intrahepatic cholangiocarcinoma; unresectable bileduct cancer in the liver.; 10019815; 10019818

• Registration Number: NL-OMON56819
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Age >=18 years.
2. ECOG 0-1.
3. 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 to randomization.
4. 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.)
5. 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.
6. Disease must be considered unresectable at the time of preoperative
evaluation.*
7. Considered candidate for general anesthesia, abdominal exploration and
hepatic artery pump placement.
8. Patients with chronic hepatitis and/or cirrhosis are eligible, but must be
Child-Pugh class A.
9. WBC >= 2,000/mcL , ANC >= 1000/mcL
10. Platelet count >= 75,000/mcL
11. Creatinine <= 1.8 mg/dL
12. Total bilirubin < 1.5 mg/dL
13. Hgb > 7 g/dL

Exclusion Criteria

1. 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.
2. Patients previously treated with systemic chemotherapy for IHC will be
non-eligible.
3. Prior treatment with FUDR.
4. Prior external beam radiation therapy to the liver.
5. Prior ablative therapy to the liver.
6. Diagnosis of sclerosing cholangitis.
7. Clinical evidence or portal hypertension (ascites, gastroesophageal varices,
or portal vein thrombosis; surgically related ascites does not exclude the
patient).
8. Active infection within one week prior to HAI placement.
9. Pregnant or lactating women.
10. 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.
11. Life expectancy <12 weeks.
12. Inability to comply with study and/or follow-up procedures.
13. History of peripheral neuropathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified