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

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ClinicalTrials.gov Identifier: NCT03097848
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : May 8, 2017
Sponsor:
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
Cancer Hospital of Yunnan provinceal
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
Information provided by (Responsible Party):
feng xiaobin, 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.

Condition or disease Intervention/treatment Phase
HCC Procedure: RFA Drug: Sorafenib Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: control group




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 1 year ]
    1 year Disease free survival


Secondary Outcome Measures :
  1. Time To Recurrence [ Time Frame: 3 year ]
    time to tumor recurrence

  2. Overall Survival [ Time Frame: 3 year ]
    overall survival

  3. postoperative complications [ Time Frame: 6 months ]
    postoperative complications diagnosed within 6 months

  4. Health economics index [ Time Frame: 3 years ]
    Health economics index within 3 years

  5. mortality [ Time Frame: 3 months ]
    mortality occured within 3 months



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097848


Contacts
Contact: Xiaobin Feng +86-2368765297 fengxiaobin200708@aliyun.com

Locations
China, Chongqing
Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: kuansheng Ma, MD         
Sponsors and Collaborators
Southwest Hospital, China
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
Cancer Hospital of Yunnan provinceal
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

Responsible Party: feng xiaobin, Clinical Professor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT03097848     History of Changes
Other Study ID Numbers: SWHB 019
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs