Lenvatinib, Sintilimab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).

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

• Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically

• At least one measurable untreated lesion

• Intrahepatic tumors can be treated with 1-2 session of SIRT

• Child-Pugh score 5-7

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

• Life expectancy of at least 3 months

• Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 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: 2023-08-10
Estimated Completion Date: 2026-08-09
Participants
Target number of participants: 30
Treatments
Experimental: Len-Sin-SIRT
Lenvatinib, sintilimab plus SIRT
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital of Guangzhou Medical University

This content was sourced from clinicaltrials.gov