Neoadjuvant TACE plus atezolizumab and bevacizumab for resectable high-risk liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm, multicenter phase II study that gives a course of transarterial chemoembolization together with systemic atezolizumab and bevacizumab prior to planned surgical resection. Eligible adults (18–75) have histologically confirmed, initially resectable hepatocellular carcinoma with high‑risk features for recurrence such as large tumor size, multiple tumors, vascular invasion, or poor differentiation. Patients receive the combined locoregional and immunotherapy/anti‑VEGF regimen, then proceed to surgery if resection remains feasible. Key outcomes include tumor response, ability to complete resection, recurrence rates, and safety/tolerability.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer Hospital Chinese Academy of Medical Science
  Beijing, Beijing Municipality, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Not yet recruiting
• The First Hospital of China Medical University
  Shenyang, Liaoning, China Not yet recruiting
• Shanxi Cancer Hospital
  Taiyuan, Shanxi, China Not yet recruiting

Study contacts

• Study coordinator: Xinyu Bi
• Email: beexy1971@163.com
• Phone: +86 (010)87787100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.