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

Hepatocellular Carcinoma Clinical Trial

— ROSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811481
• Other study ID #: [2022]662
• Status: Recruiting
• Start date: December 27, 2022
• Est. completion date: December 27, 2025

Study information

• Verified date: April 2023
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: WenBo Guo
• Phone: +8613922282028
• Email: patrickguo2008[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: December 27, 2025
• Est. primary completion date: December 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

( - ) After pathological / clinical diagnosis of hepatocellular carcinoma or radical resection of hepatocellular carcinoma; ( - ) CNLC ?a 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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Transcatheter Arterial ChEmoembolization

Intervention

Procedure:
• TACE
Transcatheter Arterial Chemoembolization

Drug:
• Regorafenib
Regorafenib alone

Locations

Country	Name	City	State
China	FirstSunYetSen	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
WenBo Guo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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	Progression-free survival for the first subsequent treatment PFS 2	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