A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma

Withdrawn before enrolling · Phase 3

Conditions studied: Intrahepatic Cholangiocarcinoma

In brief

Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.

Key facts

Study ID

NCT03081039

Run by

University of Louisville

People needed

0

Starts

2017-08-21

Expected to finish

2022-12-31

Last updated by the study team

2018-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of intrahepatic cholangiocarcinoma
• Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin > 9 g/dL
• Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl
• Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, > 50 ml/min calculated by the C-G equation
• Non-pregnant women of child bearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age)
• ECOG status ≤ 1 at screening

You may not qualify if…

• Subjects will be eligible for the study if they meet all inclusion criteria

Where it is running

• University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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