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โ† Trials
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Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC

RecruitingPhase 2Ages 18 Years - 75 YearsAllSecond Affiliated Hospital of Guangzhou Medical Uโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ70% 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 \<3ร—10\^9/L and platelet count \<50ร—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
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What it tests

  • Sin-Bev-SIRT
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Where

1 site
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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