Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC

Recruiting now · Phase 2

Conditions studied: Hepatocellular Carcinoma Non-resectable

In brief

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).

Key facts

Study ID

NCT06397222

Run by

Second Affiliated Hospital of Guangzhou Medical University

People needed

23

Starts

2024-05-01

Expected to finish

2027-04-30

Last updated by the study team

2024-05-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• the Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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