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

Summary

This is an open-label, single-arm, multicenter, prospective, phase II clinical study to evaluate the efficacy and safety of TACE combined with Atezolizumab and Bevacizumab as neoadjuvant treatment in Hepatocellular Carcinoma.

Eligibility

Inclusion Criteria:

1. Signed Informed Consent Form available
2. Patients ≥ 18 years and ≤75years of age at time of signing Informed Consent Form
3. Diagnosis of HCC confirmed by histology
4. 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)
5. Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator
6. Child-Pugh A
7. ECOG PS 0～1
8. No prior locoregional or systemic treatment for HCC
9. Negative HIV test at screening

Exclusion Criteria:

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC
2. Clinically diagnosed hepatic encephalopathy in the last 6 months
3. Autoimmune hepatitis (requiring liver puncture)
4. History of organ transplantation
5. Clinical symptoms of pleural effusion, ascites, pericardial effusion, and any history of kidney disease or nephrotic syndrome
6. Treatment with investigational therapy within 28 days prior to initiation of study treatment
7. Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
8. A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
9. Known severe allergic reaction to contrast (e.g., anaphylaxis).
10. Pregnancy or lactating women.
11. Inability to provide informed consent.

Conditions4

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