Sintilimab, Bevacizumab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial
Overview
- Phase
- Phase 2
- Intervention
- Sin-Bev-SIRT
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Progression free survival (PFS) according to mRECIST
- Status
- Recruiting
- Last Updated
- last year
Overview
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).
Detailed Description
This is a single-center, prospective study to evaluate the efficacy and safety of sintilimab, bevacizumab plus SIRT (Sin-Bev-SIRT) in patient with unresectable HCC. 23 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in this study. The patients will receive sintilimab (200mg I.V. Q3W) and bevacizumab (7.5mg/kg I.V. Q3W) at 3-7 days after SIRT. Sintilimab and bevacizumab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. The primary end point of this study is Progression free survival (PFS) per mRECIST. The secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs).
Investigators
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 (TAE), radiotherapy, systemic therapy for HCC
- •History of organ and cell transplantation
- •Prior esophageal and/or gastric varices bleeding
- •Hepatic dysfunction, such as ascites, esophagogastric varices, hepatic encephalopathy
- •Evidence of portal hypertension with high risk of bleeding
Arms & Interventions
Sin-Bev-SIRT
Sintilimab, Bevacizumab plus SIRT
Intervention: Sin-Bev-SIRT
Outcomes
Primary Outcomes
Progression free survival (PFS) according to mRECIST
Time Frame: 3 years
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Secondary Outcomes
- Progression free survival (PFS) according to RECIST 1.1(3 years)
- Objective response rate (ORR)(3 years)
- Adverse Events (AEs)(3 years)
- Overall survival (OS)(3 years)
- Disease control rate (DCR)(3 years)