Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo

Korábbi kezelés

• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment

Más betegség

• Autoimmune hepatitis (requiring liver puncture)
• History of organ transplantation
• Clinical symptoms of pleural effusion, ascites, pericardial effusion, and any history of kidney disease or nephrotic syndrome
• Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
• Known severe allergic reaction to contrast (e.g., anaphylaxis).

Egyéb

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC
• Clinically diagnosed hepatic encephalopathy in the last 6 months
• Pregnancy or lactating women.
• Inability to provide informed consent.

• Signed Informed Consent Form available
• Patients ≥ 18 years and ≤75years of age at time of signing Informed Consent Form
• Diagnosis of HCC confirmed by histology
• Initially resectable with high-risk recurrence factors. High-risk features for resected patients include tumor size \>5 cm, tumor number \>3, vascular invasion (microvascular invasion or macrovascular invasion - Vp1/Vp2 - of the portal vein) and poor tumor differentiation (defined as Grade 3 or 4).
  • Up to three tumors, with largest tumor \>5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) or poor tumor differentiation (Grade 3 or 4) Four or more tumors, with largest tumor ≤5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) or poor tumor differentiation (Grade 3 or 4) Up to three tumors, with largest tumor ≤5 cm with vascular invasion (microvascular invasion or macrovascular invasion of Vp1/Vp2) and/or poor tumor differentiation (Grade 3 or 4)
• Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator
• Child-Pugh A
• ECOG PS 0～1
• No prior locoregional or systemic treatment for HCC
• Negative HIV test at screening