Recruiting
Phase 2

Gemcitabine & Oxaliplatin

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04891289

Conditions

Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gemcitabine

Oxaliplatin

Dexamethasone

Floxuridine (FUDR)

Implanted Medical Device

Study Details

Brief summary:

This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.

Conditions

Intrahepatic Cholangiocarcinoma

Study ID

NCT04891289

Start date

May 7, 2021

Status verified date

Aug, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years
  • 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 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
  • Platelet count ≥ 75,000/mcL
  • Creatinine ≤ 1.8 mg/dL
  • Total bilirubin < 1.5 mg/dL
  • Hgb > 7 g/dL The % involvement of the liver will be determined by radiologists after review of imaging

Exclusion Criteria:

  • 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.
  • 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.
  • 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. There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HAI FUDR plus GemOx (Arm 1)

Surgical HAI pump placement. 2. HAI FUDR \[(0.12 mg/kg/day) x wt (kg) x (30ml) / pump flow rate \] and dexamethasone \[1 mg/day \* 30\] / pump flow rate \] on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. 3. Gemcitabine (800 mg/m2 IV over 30 minutes) and oxaliplatin (85 mg/ m2 IV over 120 minutes on Days 1 and 15 of each cycle; however, for patients in Arm 1, initiation of systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first dose of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.

active comparator: GemOx alone (Arm 2)

Gemcitabine (800 mg/m2 IV over 30 minutes) and oxaliplatin (85 mg/m2 IV over approximately 120 minutes) on Days 1 and 15 of each 28-day cycle.For patients in Arm 2, systemic therapy will be administered on Days 1 and Day 15 of each Cycle on a 28-day cycle basis, compromised of Gemcitabine and Oxaliplatin. If a patient randomized to Arm 2 has intrahepatic progression on any follow-up scan during study treatment, that patient will be eligible to crossover to Arm 1 and commence to pump placement surgery and HAI FUDR treatment. Patients with any extrahepatic progression will not be eligible to utilize the crossover arm. Arm 2 patients will have 28 days from date of the scan showing intrahepatic progression to proceed to the crossover arm.

Interventions

Gemcitabine

See arm for details.

Oxaliplatin

See arm for details.

Dexamethasone

See arm for details.

Floxuridine (FUDR)

See arm for details.

Implanted Medical Device

Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy

Primary outcome measure

  • assess progression-free survival (PFS) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Andrea Cercek, MD

646-888-4189cerceka@mskcc.org

William Jarnagin, MD

212-639-7601

Locations

Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Andrea Cercek, MD

646-888-4189

Principal Investigator:

Andrea Cercek, MD

Memorial Sloan Kettering Monmouth - Limited Protocol Activities

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Bergen - Limited Protocol Activities

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Commack - Limited Protocol Activities

Recruiting

Commack, New York, United States, 11725

Contacts

Andrea Cercek, MD

646-888-4189

Principal Investigator:

Andera Cercek, MD

Memorial Sloan Kettering Westchester - Limited Protocol Activities

Recruiting

Harrison, New York, United States, 10604

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Andrew Cercek, MD

646-888-4189

Memorial Sloan Kettering Nassau - Limited Protocol Activities

Recruiting

Uniondale, New York, United States, 11553

Contacts

Andrea Cercek, MD

646-888-4189

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Gemcitabine
  • Oxaliplatin
  • Floxuridine
  • Dexamethasone Pump
  • 20-348

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-17.