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

Recruiting

• Conditions: Hepatocellular Carcinoma; Transcatheter Arterial ChEmoembolization; Regorafenib
• Interventions: Procedure: TACE; Drug: Regorafenib

• Registration Number: NCT05811481
• Lead Sponsor: WenBo Guo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-27
• Study First Submitted: 2023-03-26
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-12
• Last Update Submitted: 2023-04-12
• Study First Posted: 2023-04-13
• Last Update Posted: 2023-04-13
• Primary Completion: 2024-12-27
• Study Completion: 2025-12-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Two treatment groups	TACE	Regorafenib + TACE
Two treatment groups	Regorafenib	Regorafenib + TACE
Treatment ate group	Regorafenib	Regorafinib

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

FirstSunYetSen; 🇨🇳 Guangzhou, Guangdong, China