NCT07239245RecruitingPhase 2
Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo
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
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 12 Nov 2025
- Primary completion date
- 10 Nov 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07239245
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 12 Nov 2025 to the primary completion date, 10 Nov 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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).
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| Shanxi Cancer hospital Coordinator of this site? Confirm its status | Taiyuan | China | Not yet recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.