HCCNCT07009470
A Multicenter, Prospective Study of Perioperative Finotonlimab Combined With Bevacizumab in Resectable Hepatocellular Carcinoma Patients With High-Risk Factors for Recurrence
A study testing Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar) and TACE in people with HCC, run by Tongji Hospital at 1 site in China.
Trial summary
For patients with early- to mid-stage hepatocellular carcinoma (HCC), the five-year postoperative recurrence and metastasis rate remains as high as 70%, significantly impacting patient prognosis.Therefore, perioperative therapy may be considered for HCC patients with these high-risk features . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar) and TACE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 28 Oct 2028
- Phase
- Interventional
- 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
- - Informed Consent Voluntarily signed informed consent after full understanding of the study, with commitment to comply with all protocol requirements and assessment schedules.
- Age 18-75 years inclusive.
- Diagnosis Histologically/cytologically confirmed hepatocellular carcinoma (HCC) OR clinically diagnosed HCC per 2024 Chinese Guidelines for Primary Liver Cancer.
- Tumor Status
- Meets ONE of the following:
- Multifocal tumors (2-4 lesions)
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- Single lesion >5 cm in longest diameter
- Stage IIIa HCC with Vp1/Vp2/Vp3 portal vein tumor thrombus
- Resectability Technically amenable to curative resection per surgeon assessment.
- Liver Function Child-Pugh class A.
- Performance Status ECOG PS 0-1.
- Prior Therapy No previous systemic treatment for HCC.
- Measurable Disease
- ≥1 radiologically measurable lesion per mRECIST.
- Organ Function (1) Hematological:
- ANC ≥1.5×10⁹/L
- Hemoglobin ≥90 g/L
- Platelets ≥50×10⁹/L (2) Hepatic:
- Total bilirubin ≤1.5×ULN
- AST/ALT ≤2.5×ULN
- Albumin ≥28 g/L (3) Coagulation:
- INR ≤2.3 OR PT prolongation ≤3 sec vs control (4) Renal:
- eGFR >90 mL/min/1.73m² (CKD-EPI)
- Contraception
- Women of childbearing potential: Negative serum pregnancy test within 7 days prior to enrollment.
- All subjects: Use highly effective contraception during treatment and for 180 days post-last dose.
Who cannot join
- Pregnancy/Lactation Women who are pregnant or breastfeeding.
- Concurrent Malignancy
- History of other malignancies within 5 years except:
- Curatively treated basal cell carcinoma
- Cervical carcinoma in situ
- Papillary thyroid carcinoma
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- Drug Hypersensitivity Known allergy to finolizumab, bevacizumab, or their excipients.
- Bleeding Risk History of upper GI bleeding OR active hemorrhagic disorders.
- Uncontrolled Cardiac Disease
- Clinically significant cardiac conditions including:
- NYHA Class II+ heart failure
- Unstable angina
- Myocardial infarction within 1 year
- Clinically significant arrhythmias requiring intervention
- Autoimmune Disorders Active autoimmune diseases or history of autoimmune disorders.
- Immunodeficiency
- Immunodeficiency conditions including:
- HIV positive status
- Primary/secondary immunodeficiency
- History of organ/bone marrow transplantation
- Psychiatric Conditions Severe psychiatric disorders OR substance abuse involving psychotropic drugs.
- Uncontrolled Comorbidities Severe uncontrolled recurrent infections OR other significant uncontrolled comorbidities.
- Investigator Discretion Any condition deemed ineligible by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
For patients with early- to mid-stage hepatocellular carcinoma (HCC), the five-year postoperative recurrence and metastasis rate remains as high as 70%, significantly impacting patient prognosis.Therefore, perioperative therapy may be considered for HCC patients with these high-risk features .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar)Drug
First, perform a single session of TACE. Followed by three cycles of neoadjuvant therapy with Finotonlimab combined with bevacizumab. Proceed with curative resection. Finally, initiate postoperative adjuvant targeted-immunotherapy . Finotonlimab: intravenously every three weeks ,200mg. bevacizumab：intravenously every three weeks , with a dosage based on body weight: 15 mg (≤60 kg) .
TACEProcedure or surgery
Initial Perform a single session of TACE procedure.TACE treatment is strictly in accordance with the Chinese guidelines for clinical practice of transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (2023 Edition).
| Study group | Role | What they receive |
|---|---|---|
| TACE combined with targeted-immunotherapy | Experimental | Not described Receives: Drug: Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar); Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year DFS rate and 2-year OS rate
2-year DFS rate refers to the proportion of patients remaining free of disease recurrence or death for over 2 years, measured from the date of surgery.
2-year OS rate refers to the proportion of subjects surviving in the trial cohort at the 2-year follow-up mark, calculated from the initiation of neoadjuvant therapy.
Measured: 2years
Secondary outcomes (5)
MPR
Defined as the presence of ≥70% tumor necrosis in the tumor bed and regional lymph nodes of resected specimens following curative resection.
Measured: 9 weeks
pCR
Defined as the absence of viable tumor cells in both the primary tumor site and regional lymph nodes of resected specimens after curative surgery.
Measured: 9 weeks
R0 rate
The tumor was completely removed with negative margins, meaning no residual tumor
Measured: 9 weeks
EFS
Event Free Survival
Measured: 2 years
safety
Safety profiles during neoadjuvant therapy and postoperative period were systematically assessed per CTCAE v5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start10 Feb 2025
- Primary completion28 Apr 2028 (estimated)
- Study completion28 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyong Huang, Tongji Hospital
- Investigators
- Zhiyong Huang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009470
- Sponsor's protocol ID
- HCC-SCT-TJ01
- Status last verified
- Feb 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Study of Perioperative Finotonlimab Combined With Bevacizumab in Resectable Hepatocellular Carcinoma Patients With High-Risk Factors for Recurrence
- ClinicalTrials.gov ID
- NCT07009470
- Acronym / sponsor ID
- HCC-SCT-TJ01
- Conditions
- HCC
- Keywords
- adjuvant regimen, TACE combined with targeted-immunotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 28 Apr 2028 (estimated)
- Study completion
- 28 Oct 2028 (estimated)
- First posted
- 6 Jun 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.
For patients with early- to mid-stage hepatocellular carcinoma (HCC), the five-year postoperative recurrence and metastasis rate remains as high as 70%, significantly impacting patient prognosis.Therefore, perioperative therapy may be considered for HCC patients with these high-risk features .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE combined with targeted-immunotherapy | Experimental | Drug: Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar), Procedure: TACE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- - Informed Consent Voluntarily signed informed consent after full understanding of the study, with commitment to comply with all protocol requirements and assessment schedules.
- Age 18-75 years inclusive.
- Diagnosis Histologically/cytologically confirmed hepatocellular carcinoma (HCC) OR clinically diagnosed HCC per 2024 Chinese Guidelines for Primary Liver Cancer.
- Tumor Status
- Multifocal tumors (2-4 lesions)
Key exclusion criteria (23 listed)
- Pregnancy/Lactation Women who are pregnant or breastfeeding.
- Concurrent Malignancy
- Curatively treated basal cell carcinoma
- Cervical carcinoma in situ
- Papillary thyroid carcinoma
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 |
|---|---|---|
| Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar)First, perform a single session of TACE. Followed by three cycles of neoadjuvant therapy with Finotonlimab combined with bevacizumab. Proceed with curative resection. Finally, initiate postoperative adjuvant targeted-immunotherapy . Finotonlimab: intravenously every three weeks ,200mg. bevacizumab：intravenously every three weeks , with a dosage based on body weight: 15 mg (≤60 kg) . | Drug | TACE combined with targeted-immunotherapy |
| TACEInitial Perform a single session of TACE procedure.TACE treatment is strictly in accordance with the Chinese guidelines for clinical practice of transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (2023 Edition). | Procedure or surgery | TACE combined with targeted-immunotherapy |
Primary outcome
2-year DFS rate and 2-year OS rate
Time frame: 2years
2-year DFS rate refers to the proportion of patients remaining free of disease recurrence or death for over 2 years, measured from the date of surgery. 2-year OS rate refers to the proportion of subjects surviving in the trial cohort at the 2-year follow-up mark, calculated from the initiation of neoadjuvant therapy.
5 secondary outcomes
MPR
Time frame: 9 weeks
pCR
Time frame: 9 weeks
R0 rate
Time frame: 9 weeks
EFS
Time frame: 2 years
safety
Time frame: 2 years
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 6 Jun 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. This study is not recruiting at the moment.
Zhiyong Huang principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar) and TACE in people with HCC, run by Tongji Hospital at 1 site 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 26 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year DFS rate and 2-year OS rate (time frame: 2years). 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 6 Jun 2025.