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

A Phase III, Multicenter, Open-Label, Randomized Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablated Intra-Hepatic Cholangiocarcinoma

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03081039

Enrollment

Registered

2017-03-15

Start date

2017-08-21

Completion date

2022-12-31

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

cholangiocarcinoma, gemcitabine, carboplatin, cisplatin

Brief summary

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

Detailed description

Phase III, multicenter, open label, randomized study of Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone as adjuvant therapy in patients with resected or ablated intra-hepatic cholangiocarcinoma. Subjects will be randomized in a 1:1 fashion to Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone.

Interventions

DRUGCarboplatin

Arm A: Carboplatin or Cisplatin every 21 days for 6 cycles. Dose based on weight.

DRUGCisplatin

Arm A: Cisplatin or Carboplatin every 21 days for 6 cycles. Dose based on weight.

DRUGGemcitabine

Arm A: Given with either Cisplatin or Carboplatin every 21 days for 6 weeks. Dose based on individuals weight. Arm B: Gemcitabine alone every 21 days for 6 cycles. Dose based on weight.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Subjects will be randomized 1:1 to one of two treatment arms.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Overall Survival	Every three months for 4 years

Secondary

Measure	Time frame
Progression Free Survival	Every three months for 4 years.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026