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

Sponsor

WenBo Guo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05811481

Collaborator

(none)

192

Enrollment

Location

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

. 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Transcatheter Arterial ChEmoembolization Regorafenib	Procedure: TACE Drug: Regorafenib

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

192 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 27, 2022

Anticipated Primary Completion Date :

Dec 27, 2024

Anticipated Study Completion Date :

Dec 27, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Two treatment groups

Regorafenib + TACE

Procedure: TACE

Transcatheter Arterial Chemoembolization

Drug: Regorafenib

Regorafenib alone

Treatment ate group

Regorafinib

Drug: Regorafenib

Regorafenib alone

Outcome Measures

Primary Outcome Measures

Overall survival [2022.12.27-2025.09.30]
defined as the time between the start of second-line treatment and the end of follow-up / death.

Secondary Outcome Measures

Progression-free survival for the first subsequent treatment PFS 2 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FirstSunYetSen	Guangzhou	Guangdong	China	510200

Sponsors and Collaborators

WenBo Guo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

WenBo Guo, professor, First Affiliated Hospital, Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT05811481

Other Study ID Numbers:

[2022]662

First Posted:

Apr 13, 2023

Last Update Posted:

Apr 13, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Apr 13, 2023