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

W

WenBo Guo

Status

Enrolling

Conditions

Regorafenib
Transcatheter Arterial ChEmoembolization
Hepatocellular Carcinoma

Treatments

Procedure: TACE
Drug: Regorafenib

Study type

Observational

Funder types

Other

Identifiers

NCT05811481
[2022]662

Details and patient eligibility

About

. 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.

Enrollment

192 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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;

Trial design

192 participants in 2 patient groups

Two treatment groups
Description:
Regorafenib + TACE
Treatment:
Drug: Regorafenib
Procedure: TACE
Treatment ate group
Description:
Regorafinib
Treatment:
Drug: Regorafenib

Trial contacts and locations

1

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Central trial contact

WenBo Guo

Data sourced from clinicaltrials.gov

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