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Recruiting Phase 2 NCT06397222

Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC

Trial Parameters

Condition Hepatocellular Carcinoma Non-resectable
Sponsor Second Affiliated Hospital of Guangzhou Medical University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 23
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-05-01
Completion 2027-04-30
Interventions
Sin-Bev-SIRT

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * Unresectable HCC (BCLC stage B/C or CNLC II/III) with diagnosis confirmed by histology/cytology or clinically * At least one measurable untreated lesion * Intrahepatic tumors can be treated with 1-2 sessions 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 Exclusion Criteria: * tumor extent ≥70% liver occupation * Tumor thrombus involving main portal vein or both the first left and right branches of portal vein * Vena cava invasion * Central nervous system metastasis * Metastatic disease that involves major airways or blood vessels * Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (

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