Transarterial Chemoembolization With Drug-eluting Beads Plus Hepatic Arterial Infusion Chemotherapy Versus Hepatic Arterial Infusion Chemotherapy Alone for Large Hepatocellular Carcinoma

Who is this study for? Patients with large hepatocellular carcinoma
What treatments are being studied? dTACE-HAIC
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) plus hepatic artery infusion chemotherapy (HAIC) compared with HAIC alone for unresectable large hepatocellular carcinoma (HCC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients with HCC confirmed by histology/cytology or diagnosed clinically.

• The maximum HCC lesion \> 7 cm.

• Unresectable HCC evaluated by the surgeon team.

• At least one measurable intrahepatic target lesion.

• Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.

• ECOG score of performance status ≤ 1 point.

• Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range.

• Life expectancy of at least 3 months.

Locations
Other Locations
China
the Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Mingyue Cai, Dr.
cai020@yeah.net
+86-20-34156205
Backup
Kangshun Zhu, Dr.
zhksh010@163.com
+86-20-34156205
Time Frame
Start Date: 2022-02-10
Estimated Completion Date: 2026-02-09
Participants
Target number of participants: 230
Treatments
Experimental: Transarterial chemoembolization with drug-eluting beads plus hepatic arterial infusion chemotherapy
Patients will receive the combination treatment of DEB-TACE and HAIC.
Active_comparator: Hepatic arterial infusion chemotherapy
Patients will receive HAIC treatment alone.
Related Therapeutic Areas
Sponsors
Collaborators: Affiliated Hospital of Guangdong Medical University, Jiangmen Central Hospital, Hainan General Hospital, First Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan, Maoming People's Hospital, Zhongshan People's Hospital, Guangdong, China
Leads: Second Affiliated Hospital of Guangzhou Medical University

This content was sourced from clinicaltrials.gov