Regorafenib Alone or in Combined With Transcatheter Arterial ChEmoembolization in Treatment of Advanced Hepatocellular Carcinoma After First Line Targeted Therapy (ROSE)

April 12, 2023 updated by: WenBo Guo

Clinical Research and Laboratory Animal Ethics Committee of the First Affiliated Hospital of Sun Yat-sen University

. 1 Clarify the difference in efficacy of regofinib combined with TACE compared with second-line treatment of advanced liver cancer; 2. To evaluate the safety and prognostic imaging factors of regorofenib in advanced second-line therapy; 3, to explore whether it is necessary to increase the treatment of TACE in the second-line treatment of advanced HCC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with hepatocellular carcinoma

Description

Inclusion Criteria:

( - ) After pathological / clinical diagnosis of hepatocellular carcinoma or radical resection of hepatocellular carcinoma; ( - ) CNLC Ⅲa Patients with intrahepatic recurrence before (including a); ( - ) Previous failure of first-line systemic treatment; ( - ) Age: 18-75 years old; ( - ) Child-Pugh 7 points; ( - ) ECOG PS Grade 0-2; ( - ) At least one measurable lesion in the liver.

Exclusion Criteria:

( - ) Known hepatobiliary tubular cell carcinoma and mixed cell carcinoma and fibrolamellar cell carcinoma; ( - ) Previous (within 5 years) or concurrent other incurable malignant tumors; ( - ) Having received local treatment, systemic chemotherapy, radiotherapy other than TACE during the first-line systemic treatment; ( - ) During the second-line systemic treatment, I also received local treatment, systemic chemotherapy, radiotherapy other than TACE; ( - ) Serious uncontrollable systemic and other systemic diseases, such as uremia, cardiovascular and cerebrovascular accidents; ( - ) Allergy to any drug included in the study; ( - ) Pregnant or lactating women;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Two treatment groups
Regorafenib + TACE
Procedure: TACE
Transcatheter Arterial Chemoembolization
Drug: Regorafenib
Regorafenib alone
Treatment ate group
Regorafinib
Drug: Regorafenib
Regorafenib alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2022.12.27-2025.09.30
defined as the time between the start of second-line treatment and the end of follow-up / death.
2022.12.27-2025.09.30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival for the first subsequent treatment PFS 2
Time Frame: 2022.12.27-2025.09.30
defined as the time of second-line treatment initiation to the date of radiological progression or death from any cause.
2022.12.27-2025.09.30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WenBo Guo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2022

Primary Completion (Anticipated)

December 27, 2024

Study Completion (Anticipated)

December 27, 2025

Study Registration Dates

First Submitted

March 26, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2022]662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Regorafenib Alone or in Combined with Transcatheter Arterial ChEmoembolization in Treatment of Advanced Hepatocellular Carcinoma after First Line Targeted Therapy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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