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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05811481

Acronym

ROSE

Enrollment

192

Registered

2023-04-13

Start date

2022-12-27

Completion date

2025-12-27

Last updated

2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma, Regorafenib, Transcatheter Arterial ChEmoembolization

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.

Interventions

PROCEDURETACE

Transcatheter Arterial Chemoembolization

DRUGRegorafenib

Regorafenib alone

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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;

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactWenBo Guo

patrickguo2008@163.com+8613922282028

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026