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

Shanghai Jiao Tong University School of Medicine

Status: Unknown

Conditions: Adjuvant Chemotherapy; Liver Transplantation; Survival; Tumor Recurrence and Metastasis; Hepatocellular Carcinoma

Treatments: Drug: doxorubicin, 5-Fu and cisplatin; Drug: gemcitabine and oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01125020

2008BAI60B03

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 2 patient groups

gemcitabine and oxaliplatin

Active Comparator group

Treatment:

Drug: gemcitabine and oxaliplatin

doxorubicin, 5-Fu and cisplatin

Active Comparator group

Treatment:

Drug: doxorubicin, 5-Fu and cisplatin