Sintilimab, Bevacizumab Plus TACE Versus Lenvatinib Plus TACE for Advanced Stage Hepatocellular Carcinoma: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus TACE (Sin-Bev-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced stage hepatocellular carcinoma (HCC).

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

• Advanced HCC (BCLC stage C) with diagnosis confirmed pathologically or clinically

• Disease amenable to TACE

• No prior systemic therapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC

• Child-Pugh class A

• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1

• Life expectancy of at least 3 months

• At least one measurable intrahepatic lesion

• Adequate organ and hematologic function

• Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^2 IU/mL

• Patients with hepatitis C need to finish the anti-HCV treatment

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: 2023-08-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 258
Treatments
Experimental: Sin-Bev-TACE
Sintilimab, bevacizumab plus TACE
Active_comparator: Len-TACE
Lenvatinib plus TACE
Related Therapeutic Areas
Sponsors
Collaborators: Lecong Hospital, Shunde District, Foshan, Affiliated Hospital of Guangdong Medical University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Leads: Second Affiliated Hospital of Guangzhou Medical University

This content was sourced from clinicaltrials.gov

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