Resectable Hepatocellular Carcinoma With High Risk of RecurrencePhase 2ATTACHNCT07239245
Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo
A Phase 2 study testing Atezolizumab, Bevacizumab and Transarterial chemoembolization (TACE) in people with Resectable Hepatocellular Carcinoma With High Risk of Recurrence, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Hepatocellular Carcinoma With High Risk of Recurrence
- What is being tested?
- Atezolizumab, Bevacizumab and Transarterial chemoembolization (TACE)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesChina
- Study dates
- 12 Nov 2025to 10 Nov 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Child-Pugh A
- ECOG PS 0～1
- No prior locoregional or systemic treatment for HCC
- Negative HIV test at screening
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC
- Clinically diagnosed hepatic encephalopathy in the last 6 months
- 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
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
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- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
- Known severe allergic reaction to contrast (e.g., anaphylaxis).
- Pregnancy or lactating women.
- Inability to provide informed consent.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Xinyu Bi, +86 (010)87787100, beexy1971@163.com
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Gang Wu, +86(024)83283308, cmuwgzwl@126.com
- Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi
Qingxian Huang, +86(0351)4651772, yhdhuang@163.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Jinxue Zhou, +86(0371)65587787, zhoujx888@126.com
About this study
Official title: 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 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.
- Being tested
- Atezolizumab, Bevacizumab, Transarterial chemoembolization (TACE)
- Keywords
- Hepatocellular Carcinoma, Neoadjuvant therapy, TACE, Atezolizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
BevacizumabDrug
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)Procedure or surgery
TACE will be performed by clinical demand.
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab + Bevacizumab + TACE | Experimental | 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. Receives: Drug: Atezolizumab; Drug: Bevacizumab; Procedure: Transarterial chemoembolization (TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) Rate
pCR rate is defined as the proportion of participants with an absence of residual tumor at the time of surgery, as assessed by central pathological review.
Measured: At the time of surgery
Secondary outcomes (5)
Major Pathologic Response (MPR) Rate
MPR rate is defined as the proportion of participants with =<30% residual viable tumor in the tumor bed at the time of surgery, as assessed by central pathological review.
Measured: At the time of surgery
Relapse-Free Survival (RFS)
RFS is defined as the time from surgery to the first documented recurrence of disease (intrahepatic or extrahepatic) according to EASL and/or RECIST v1.1, or death from any cause.
Measured: Surgery to the first documented recurrence of disease (up to approximately 2 years)
Event-Free Survival (EFS)
EFS is defined as the time from enrollment to any of the following events (whichever occurs first): disease progression that precludes surgery, as assessed by the investigator according RECIST v1.1; local regional, or distant disease recurrence as measured by EASL and/or RECIST v1.1; or death from any cause.
Measured: Enrollment up to approximately 2 years
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Measured: Enrollment to death from any cause (up to approximately 5 years)
Treatment-related and -unrelated toxicities (AEs, SAEs) according to NCI CTCAE v5.0
Summary of adverse events by treatment arm and CTCAE (version 5.0) grade and frequency of clinically significant abnormal laboratory parameters.
Measured: From the start of treatment to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start12 Nov 2025
- Primary completion10 Nov 2027 (estimated)
- Study completion10 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatocellular Carcinoma With High Risk of RecurrenceStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Bi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239245
- Sponsor's protocol ID
- NCC5353
- Acronym
- ATTACH
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07239245
- Acronym / sponsor ID
- ATTACH / NCC5353
- Keywords
- Hepatocellular Carcinoma, Neoadjuvant therapy, TACE, Atezolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 10 Nov 2030 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab + Bevacizumab + TACE | Experimental | Drug: Atezolizumab, Drug: Bevacizumab, Procedure: Transarterial chemoembolization (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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (11 listed)
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC
- Clinically diagnosed hepatic encephalopathy in the last 6 months
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAtezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. | Drug | Atezolizumab + Bevacizumab + TACE |
| BevacizumabBevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle. | Drug | Atezolizumab + Bevacizumab + TACE |
| Transarterial chemoembolization (TACE)TACE will be performed by clinical demand. | Procedure or surgery | Atezolizumab + Bevacizumab + TACE |
Primary outcome
Pathologic Complete Response (pCR) Rate
Time frame: At the time of surgery
pCR rate is defined as the proportion of participants with an absence of residual tumor at the time of surgery, as assessed by central pathological review.
5 secondary outcomes
Major Pathologic Response (MPR) Rate
Time frame: At the time of surgery
Relapse-Free Survival (RFS)
Time frame: Surgery to the first documented recurrence of disease (up to approximately 2 years)
Event-Free Survival (EFS)
Time frame: Enrollment up to approximately 2 years
Overall Survival (OS)
Time frame: Enrollment to death from any cause (up to approximately 5 years)
Treatment-related and -unrelated toxicities (AEs, SAEs) according to NCI CTCAE v5.0
Time frame: From the start of treatment to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab, Bevacizumab and Transarterial chemoembolization (TACE) in people with Resectable Hepatocellular Carcinoma With High Risk of Recurrence, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyu Bi (+86 (010)87787100, beexy1971@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) Rate (time frame: At the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.