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

NCT05811481 | Unknown FDA Drug

• 1 other identifier: [2022]662
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Transcatheter Arterial ChEmoembolization; Regorafenib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression-free survival for the first subsequent treatment PFS 2

  2022.12.27-2025.09.30

Study Arms (2)

Two treatment groups

Regorafenib + TACE

Procedure: TACE; Drug: Regorafenib

Treatment ate group

Regorafinib

Drug: Regorafenib

Interventions

TACE PROCEDURE

Transcatheter Arterial Chemoembolization

Two treatment groups

Regorafenib DRUG

Regorafenib alone

Treatment ate group; Two treatment groups

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with hepatocellular carcinoma

You may qualify if:

• ( - ) 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.

You may not qualify if:

• ( - ) 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;

Sponsors & Collaborators

• WenBo Guo: lead

Study Sites (1)

FirstSunYetSen

Guangzhou, Guangdong, 510200, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

WenBo Guo

CONTACT

+8613922282028; patrickguo2008@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 13, 2023
• Study Start: December 27, 2022
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2025
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)