Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo
NCT ID: NCT07239245
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-11-12
2030-11-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Atezolizumab + Bevacizumab + TACE
Participants will receive Atezolizumab plus Bevacizumab on Day 1 of a 21-Day cycle, total 5 cycles( Atezolizumab plus Bevacizumab were used in combination for 4 cycles, and Bevacizumab was discontinued in cycle 5. ), after perform 2-3 transarterial chemoembolization procedure on-demand.
Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
Bevacizumab
Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
Transarterial chemoembolization (TACE)
TACE will be performed by clinical demand.
Interventions
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Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
Bevacizumab
Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
Transarterial chemoembolization (TACE)
TACE will be performed by clinical demand.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Xinyu Bi
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCC5353
Identifier Type: -
Identifier Source: org_study_id
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