Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC

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 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

Conditions4

Browse More Trials