Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC
Sintilimab, Bevacizumab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial
Second Affiliated Hospital of Guangzhou Medical University
23 participants
May 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria20
- 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
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06397222