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

HCC Clinical Trial

— ESCALATOR  

Official title:

Efficacy and Safety of Combination of Sorafenib as Preoperative Adjuvant and Latter Radiofrequency Ablation in the Treatment Of Recurrent Hepatocellular Carcinoma: A Prospective Multicenter Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03097848
• Other study ID #: SWHB 019
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2017
• Last updated: May 4, 2017
• Start date: May 4, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2017
• Source: Southwest Hospital, China
• Contact: Xiaobin Feng
• Phone: +86-2368765297
• Email: fengxiaobin200708[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HCC

Intervention

Procedure:
• RFA
for eligible cases, radiofrequency ablation will be given only.

Drug:
• Sorafenib
for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (14)

Lead Sponsor

Collaborator

Southwest Hospital, China

Cancer Hospital of Guangxi Medical University, Cancer Hospital of Yunnan provinceal, Chengdu PLA General Hospital, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Guangxi Medical University, Henan Cancer Hospital, Hunan Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Sichuan Provincial People's Hospital, The First People's Hospital of Yunnan, The Second Affiliated Hospital of Chongqing Medical University, Xiangya Hospital of Central South University, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	1 year Disease free survival	1 year
Secondary	Time To Recurrence	time to tumor recurrence	3 year
Secondary	Overall Survival	overall survival	3 year
Secondary	postoperative complications	postoperative complications diagnosed within 6 months	6 months
Secondary	Health economics index	Health economics index within 3 years	3 years
Secondary	mortality	mortality occured within 3 months	3 months