Hepatocellular Carcinoma (HCC)NCT07272265
The Effectiveness and Safety in High-risk Patients Receiving First-line Atezolizumab and Bevacizumab Combined With HAIC for HCC: a Retrospective Study
A study testing Atezolizumab & Bevacizumab and FOLFOX-HAIC in people with Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a multicenter，retrospective study to explore the effectiveness and safety of Atezo/Bev plus hepatic artery infusion chemotherapy (HAIC) among adult patients with high-risk HCC in real-world clinical practice in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Atezolizumab & Bevacizumab and FOLFOX-HAIC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2020to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years at the initiation of Atezo/Bev plus HAIC
- Initiating Atezo/Bev between 28 October 2020 and 31 June 2025
- Diagnosed with high-risk HCC as evidenced clinically or by radiology, histology or cytology before or at the initiation of Atezo/Bev plus HAIC. The evidence of being diagnosed as "high-risk" was based on the IMbrave 150, including any of the following:
- tumor invasion of the main trunk or contralateral branch of the portal vein (Vp4)
- bile duct invasion
- tumor occupancy of 50% or more of the liver
- At least one visit record after the initiation of Atezo/Bev plus HAIC
Who cannot join
- Diagnosed with concomitant cancer except for basal cell carcinoma before or at the initiation of Atezo/Bev plus HAIC
- Participating in interventional clinical studies before or at initiating Atezo/Bev plus HAIC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness and Safety in High-risk Patients Receiving First-line Atezolizumab and Bevacizumab Combined With Hepatic Arterial Infusion Chemotherapy of FOLFOX for HCC: a Retrospective Study
This is a multicenter，retrospective study to explore the effectiveness and safety of Atezo/Bev plus hepatic artery infusion chemotherapy (HAIC) among adult patients with high-risk HCC in real-world clinical practice in China. Eligible patients diagnosed with high-risk HCC initiating the study treatment of interest between 28 October 2020 and 31 June 2025 will be included in this study. Secondary data from medical records of approximately 10 sites across China will be utilized.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Atezolizumab & Bevacizumab, FOLFOX-HAIC
- Keywords
- FOLFOX-HAIC, Atezolizumab, Bevacizumab, high-risk HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atezolizumab & BevacizumabDrug
Atezolizumab 1200mg \& Bevacizumab 15mg/kg Q3W
FOLFOX-HAICProcedure or surgery
hepatic artery infusion chemotherapy of oxaliplatin, leucovorin, and fluorouracil
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX+TA | Experimental | FOLOFOX-HAIC plus Atezolizumab and Bevacizumab Receives: Drug: Atezolizumab & Bevacizumab; Procedure: FOLFOX-HAIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
defined as time from index date to death from any cause.
Measured: 6 months
Secondary outcomes (6)
Real-world progression-free survival (rwPFS)
defined as time from index date to the earlier of clinician-anchored progressive disease (may include but are not limited to local tumor progression, disease recurrence, new metastasis, or clinical progression anchored by clinicians) or death from any cause.
Measured: 6 months
Time to discontinuation (TTD)
defined as time from the initiation to discontinuation of Atezo/Bev plus HAIC.
Measured: 6 months
Time to next treatment (TTNT)
defined as time from the initiation of Atezo/Bev plus HAIC to the initiation of next systemic treatment.
Measured: 6 months
Serum alpha-fetoprotein (AFP) reduction
defined as > 50% reduction in AFP level after 3 months (± 4 weeks) of the initiation of Atezo/Bev plus HAIC.
Measured: 6 months
Prothrombin induced by the absence of vitamin K or antagonist- II (PIVKA-II) reduction
defined as > 50% reduction in PIVKA-II level after 3 months (± 4 weeks) of the initiation of Atezo/Bev plus HAIC.
Measured: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start28 Oct 2020
- Primary completion31 May 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272265
- Sponsor's protocol ID
- HAIC+TA Retrospective
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety in High-risk Patients Receiving First-line Atezolizumab and Bevacizumab Combined With Hepatic Arterial Infusion Chemotherapy of FOLFOX for HCC: a Retrospective Study
- ClinicalTrials.gov ID
- NCT07272265
- Acronym / sponsor ID
- HAIC+TA Retrospective
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- FOLFOX-HAIC, Atezolizumab, Bevacizumab, high-risk HCC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 9 Dec 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 a multicenter，retrospective study to explore the effectiveness and safety of Atezo/Bev plus hepatic artery infusion chemotherapy (HAIC) among adult patients with high-risk HCC in real-world clinical practice in China. Eligible patients diagnosed with high-risk HCC initiating the study treatment of interest between 28 October 2020 and 31 June 2025 will be included in this study. Secondary data from medical records of approximately 10 sites across China will be utilized.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOX+TA | Experimental | Drug: Atezolizumab & Bevacizumab, Procedure: FOLFOX-HAICFOLOFOX-HAIC plus Atezolizumab and Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥ 18 years at the initiation of Atezo/Bev plus HAIC
- Initiating Atezo/Bev between 28 October 2020 and 31 June 2025
- Diagnosed with high-risk HCC as evidenced clinically or by radiology, histology or cytology before or at the initiation of Atezo/Bev plus HAIC. The evidence of being diagnosed as "high-risk" was based on the IMbrave 150, including any of the following:
- At least one visit record after the initiation of Atezo/Bev plus HAIC
Key exclusion criteria (2 listed)
- Diagnosed with concomitant cancer except for basal cell carcinoma before or at the initiation of Atezo/Bev plus HAIC
- Participating in interventional clinical studies before or at initiating Atezo/Bev plus HAIC
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 |
|---|---|---|
| Atezolizumab & BevacizumabAtezolizumab 1200mg \& Bevacizumab 15mg/kg Q3W | Drug | FOLFOX+TA |
| FOLFOX-HAIChepatic artery infusion chemotherapy of oxaliplatin, leucovorin, and fluorouracil | Procedure or surgery | FOLFOX+TA |
Primary outcome
overall survival (OS)
Time frame: 6 months
defined as time from index date to death from any cause.
6 secondary outcomes
Real-world progression-free survival (rwPFS)
Time frame: 6 months
Time to discontinuation (TTD)
Time frame: 6 months
Time to next treatment (TTNT)
Time frame: 6 months
Serum alpha-fetoprotein (AFP) reduction
Time frame: 6 months
Prothrombin induced by the absence of vitamin K or antagonist- II (PIVKA-II) reduction
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atezolizumab & Bevacizumab and FOLFOX-HAIC in people with Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 9 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
overall survival (OS) (time frame: 6 months). 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 9 Dec 2025.