Efficacy and Safety of Sorafenib as Adjuvant and Latter Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma

Not Applicable

• Conditions: HCC
• Interventions: Procedure: RFA; Drug: Sorafenib

• Registration Number: NCT03097848
• Lead Sponsor: Southwest Hospital, China

Brief Summary

Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study.

Detailed Description

Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study. Eligible cases will be assigned into the experimental group and the control group. For experiment group, sorafenib tablet will be given for two weeks, and then perform radiofrequency ablation. For the control group, RFA will be performed immediately.

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-03-31
• Study Start: 2017-05-04
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-08
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Aged from 18 to 75 years old
• Without gender restriction
• With a favorable liver function of Child-Pugh A to B
• No contraindications to RFA and anesthesia
• Diagnosed with Recurrent HCC
• Signed informed consent.

Exclusion Criteria

• Cancer thrombosis in major vessels/ extrahepatic metastasis
• Uncontrollable ascites or variceal bleeding
• Impairment in liver function
• Severe disorders in vital organ
• Accompanied with other tumors or infectious disease except hepatitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sorafenib+RFA group	RFA	for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation
Sorafenib+RFA group	Sorafenib	for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation
RFA group	RFA	for eligible cases, RFA will be given only.

Primary Outcome Measures

Name	Time	Method
Disease free survival	1 year	1 year Disease free survival

Secondary Outcome Measures

Name	Time	Method
Overall Survival	3 year	overall survival
Time To Recurrence	3 year	time to tumor recurrence
postoperative complications	6 months	postoperative complications diagnosed within 6 months
Health economics index	3 years	Health economics index within 3 years
mortality	3 months	mortality occured within 3 months

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China