Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC

Trial Title: Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC

NCT ID: NCT06397222

Condition: Hepatocellular Carcinoma Non-resectable

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular

Conditions: Keywords:
Hepatocellular Carcinoma
Sintilimab
Bevacizumab
Yttrium-90

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Sin-Bev-SIRT
Description: Sintilimab 200mg I.V. q3w and bevacizumab 7.5mg/kg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab and bevacizumab will last up to 24 months. Patients will be allowed to have sintilimab or bevacizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
Arm group label: Sin-Bev-SIRT

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).

Criteria for 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 - Use of immunosuppressive medications within 4 weeks prior to the first dose of study treatment - Major surgical procedure or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose of study treatment - Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion, surgical or localized treatment, or ongoing drug therapy - Peripheral blood white blood cell count <3×10^9/L and platelet count <50×10^9/L - Prolonged prothrombin time >4 seconds - Severe organ (heart, lung, kidney) dysfunction - History of other malignancies - Co-infection with hepatitis B and C viruses - Human immunodeficiency virus infection - Pregnant or lactating patients

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: the Second Affiliated Hospital of Guangzhou Medical University

Address:
City: Guangzhou
Zip: 510260
Country: China

Status: Recruiting

Contact:
Last name: Mingyue Cai, Dr.

Phone: +86-20-34156205
Email: cai020@yeah.net

Contact backup:
Last name: Kangshun Zhu, Dr.

Phone: +86-20-34156205
Email: zhksh010@163.com

Start date: May 1, 2024

Completion date: April 30, 2027

Lead sponsor:
Agency: Second Affiliated Hospital of Guangzhou Medical University
Agency class: Other

Source: Second Affiliated Hospital of Guangzhou Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06397222