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

RecruitingPhase 2Ages 18 Years - 75 YearsAllCancer Institute and Hospital, Chinese Academy ofโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Signed Informed Consent Form available 2. Patients โ‰ฅ 18 years and โ‰ค75years 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 โ‰ค5 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 โ‰ค5 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๏ฝž1 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.
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What it tests

  • Atezolizumab
  • Bevacizumab
  • Transarterial chemoembolization (TACE)
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Where

4 sites
Cancer Hospital Chinese Academy of Medical Science
Beijing, China
Henan Cancer Hospital
Zhengzhou, China
The First Hospital of China Medical University
Shenyang, China
Shanxi Cancer Hospital
Taiyuan, 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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