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

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

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.

Study Overview

• Status: Unknown
• Conditions: HCC
• Intervention / Treatment: Procedure: RFA; Drug: Sorafenib

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 Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaobin Feng; Phone Number: +86-2368765297; Email: fengxiaobin200708@aliyun.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Southwest Hospital
      • Contact: kuansheng Ma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sorafenib+RFA group; for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation	Procedure: RFA; for eligible cases, radiofrequency ablation will be given only.; Other Names: control group; Drug: Sorafenib; for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation; Other Names: experimental group
Active Comparator: RFA group; for eligible cases, RFA will be given only.	Procedure: RFA; for eligible cases, radiofrequency ablation will be given only.; Other Names: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	1 year Disease free survival	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Collaborators: Xiangya Hospital of Central South University; Henan Cancer Hospital; Hunan Cancer Hospital; Xinqiao Hospital of Chongqing; The Second Affiliated Hospital of Chongqing Medical University; Sichuan Provincial People's Hospital; First Affiliated Hospital of Chongqing Medical University; Chengdu PLA General Hospital; Sichuan Cancer Hospital and Research Institute; Yunnan Cancer Hospital; Cancer Hospital of Guangxi Medical University; First Affiliated Hospital of Guangxi Medical University; The First People's Hospital of Yunnan

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2017
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: SWHB 019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No