Second Affiliated Hospital of Guangzhou Medical University
Phase
Phase 2
Started
2024-05-01
Last updated
2024-05-07
Condition(s) studied
Hepatocellular Carcinoma Non-resectable
Investigational drug(s) / intervention(s)
Sin-Bev-SIRT
Sin-Bev-SIRT: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Progression free survival (PFS) according to mRECIST — 3 years The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Trial sites (1)
Facility
City
Region
Status
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
More Second Affiliated Hospital of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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