Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125020

Enrollment

150

Registered

2010-05-18

Start date

2008-12-31

Completion date

2010-12-31

Last updated

2010-05-18

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

Conditions

Adjuvant Chemotherapy, Hepatocellular Carcinoma, Liver Transplantation, Survival, Tumor Recurrence and Metastasis

Brief summary

The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.

Interventions

DRUGgemcitabine and oxaliplatin

Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.

DRUGdoxorubicin, 5-Fu and cisplatin

Doxorubicin 20mg/m2 (days 1, 3), 5-Fu 300mg/m2 (days 1-5) and cisplatin 20mg/m2 (days 1-3) delivered as an intravenous infusion, given every 28days and repeat six times.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and May 2010 are potentially eligible for enrollment.

Exclusion criteria

* Age less than 18 years * Treatment with other postoperative adjuvant chemotherapy * Survival is less than 3 months after liver transplantation * Inability to provide written informed consent prior to study entry

Design outcomes

Primary

Measure	Time frame	Description
tumor recurrence and metastasis	within the first year after liver transplantation	Examination of tumor recurrence include serum levels of alpha-fetoprotein(AFP), chest radiography, abdominal ultrasonography, chest or abdominal computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy

Secondary

Measure	Time frame	Description
Postoperative survival	within the first year after liver transplantation	Postoperative survival include rates of disease-free survival (DFS), overall survival(OS), tumor recurrence and death.

Countries

China

Contacts

Primary ContactJun-Yi Wu, MM

wjy8541@126.com0086-021-63240090

Outcome results

None listed

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