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

Efficacy and Safety of Transarterial Chemoembolization (TACE) Combined With Atezolizumab Plus Bevacizumab in Neoadjuvant Therapy for Patients With Hepatocellular Carcinoma: an Open-label, Single-arm, Multicenter, Prospective, Phase II Clinical Study

This study will try combining TACE with atezolizumab and bevacizumab before surgery to see if it shrinks tumors and reduces the chance of recurrence for people with resectable hepatocellular carcinoma who are at high risk of coming back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: Atezolizumab, Bevacizumab
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT07239245 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed resectable hepatocellular carcinoma and high‑risk features for recurrence (for example, tumor >5 cm, multiple tumors, vascular invasion, or poor differentiation) who are fit for TACE and surgery.

Not a fit: Patients with unresectable disease, extensive multifocal tumors outside the study criteria, poor liver function, or contraindications to immunotherapy or anti‑VEGF treatment are unlikely to benefit from this neoadjuvant approach.

Why it matters

Potential benefit: If successful, this approach could shrink tumors before surgery, make resections more effective, and lower the risk of cancer coming back in high‑risk patients.

How similar studies have performed: Atezolizumab plus bevacizumab has improved outcomes in advanced HCC, and early-phase work combining TACE with immunotherapy has shown promising signals, but neoadjuvant use before resection remains investigational.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 3 other locations

• 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

Conditions Resectable Hepatocellular Carcinoma With High Risk of Recurrence; Hepatocellular Carcinoma; Neoadjuvant therapy; TACE; Atezolizumab