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

Primary Purpose

HCC

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RFA
Sorafenib
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sorafenib+RFA group

RFA group

Arm Description

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

for eligible cases, RFA will be given only.

Outcomes

Primary Outcome Measures

Disease free survival
1 year Disease free survival

Secondary Outcome Measures

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

Full Information

First Posted
March 21, 2017
Last Updated
May 4, 2017
Sponsor
Southwest Hospital, China
Collaborators
Chengdu PLA General Hospital, Sichuan Provincial People's Hospital, Sichuan Cancer Hospital and Research Institute, Hunan Cancer Hospital, Cancer Hospital of Guangxi Medical University, The First People's Hospital of Yunnan, Yunnan Cancer Hospital, Xiangya Hospital of Central South University, Xinqiao Hospital of Chongqing, The Second Affiliated Hospital of Chongqing Medical University, Henan Cancer Hospital, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03097848
Brief Title
Efficacy and Safety of Sorafenib as Adjuvant and Latter Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
Collaborators
Chengdu PLA General Hospital, Sichuan Provincial People's Hospital, Sichuan Cancer Hospital and Research Institute, Hunan Cancer Hospital, Cancer Hospital of Guangxi Medical University, The First People's Hospital of Yunnan, Yunnan Cancer Hospital, Xiangya Hospital of Central South University, Xinqiao Hospital of Chongqing, The Second Affiliated Hospital of Chongqing Medical University, Henan Cancer Hospital, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sorafenib+RFA group
Arm Type
Experimental
Arm Description
for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation
Arm Title
RFA group
Arm Type
Active Comparator
Arm Description
for eligible cases, RFA will be given only.
Intervention Type
Procedure
Intervention Name(s)
RFA
Other Intervention Name(s)
control group
Intervention Description
for eligible cases, radiofrequency ablation will be given only.
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
experimental group
Intervention Description
for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation
Primary Outcome Measure Information:
Title
Disease free survival
Description
1 year Disease free survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time To Recurrence
Description
time to tumor recurrence
Time Frame
3 year
Title
Overall Survival
Description
overall survival
Time Frame
3 year
Title
postoperative complications
Description
postoperative complications diagnosed within 6 months
Time Frame
6 months
Title
Health economics index
Description
Health economics index within 3 years
Time Frame
3 years
Title
mortality
Description
mortality occured within 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaobin Feng
Phone
+86-2368765297
Email
fengxiaobin200708@aliyun.com
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
kuansheng Ma, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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