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

NCT ID: NCT03097848

Last Updated: 2017-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-04

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HCC

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sorafenib+RFA group

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

Group Type EXPERIMENTAL

RFA

Intervention Type PROCEDURE

for eligible cases, radiofrequency ablation will be given only.

Sorafenib

Intervention Type DRUG

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

RFA group

for eligible cases, RFA will be given only.

Group Type ACTIVE_COMPARATOR

RFA

Intervention Type PROCEDURE

for eligible cases, radiofrequency ablation will be given only.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RFA

for eligible cases, radiofrequency ablation will be given only.

Intervention Type PROCEDURE

Sorafenib

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

control group experimental group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chengdu PLA General Hospital

OTHER

Sponsor Role collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role collaborator

Hunan Cancer Hospital

OTHER

Sponsor Role collaborator

Cancer Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

The First People's Hospital of Yunnan

OTHER

Sponsor Role collaborator

Yunnan Cancer Hospital

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

feng xiaobin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiaobin Feng

Role: CONTACT

+86-2368765297

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

kuansheng Ma, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SWHB 019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RFA Versus SBRT for Recurrent Small HCC
NCT04047173 COMPLETED PHASE3