HCC - Hepatocellular CarcinomaPhase 2/3ABATE-MASLDNCT07285850
The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD
A Phase 2/3 study testing Sequential treatment of bevacizumab combined with atezolizumab (sequential group) and Simultaneous treatment of bevacizumab combined with atezolizumab (same period group) in people with HCC - Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- Sequential treatment of bevacizumab combined with atezolizumab (sequential group) and Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2025to 30 Aug 2026
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Excessive alcohol consumption (weekly ethanol intake: males < 210 g, females < 140 g)
- Tumor lesions previously treated with targeted therapy, immunotherapy, TACE, or radiotherapy
- Pregnant or breastfeeding women, or positive pregnancy test at baseline
- Central nervous system metastases diagnosed by CT, MRI, or PET-CT
- Participation in another clinical drug or therapy trial within 4 weeks before first study dose
- Major surgery within 4 weeks prior to first study dose, or incomplete recovery from surgery
Show all 25Show fewer
- Radiotherapy within 2 weeks before first study dose
- History or presence of primary immunodeficiency or active autoimmune disease
- History of organ transplantation or hematopoietic stem cell transplantation
- Current use of immunosuppressants or corticosteroids (>10 mg/day prednisone or equivalent) within 2 weeks
- Positive for HIV antibody or Treponema pallidum antibody, or active hepatitis B/C infection
- Allergy to recombinant humanized PD-1 monoclonal antibody, VEGF monoclonal antibody, or components
- Symptomatic pleural effusion, pericardial effusion, or ascites requiring clinical intervention
- Severe cardiovascular disease within 12 months (e.g., CAD, CHF ≥ II, arrhythmias, MI)
- Events within 6 months before first dose (e.g., DVT, PE, MI, PCI, ACS, CABG, stroke, TIA, embolism)
- History of GI surgery, obstruction, bleeding, dysfunction, or malabsorption affecting drug absorption
- Severe uncontrolled infection or comorbidity, or moderate/severe renal impairment
- Active pulmonary disease (interstitial pneumonia, COPD, asthma, tuberculosis history)
- Abnormal coagulation (INR > 2.0, PT > 16 s), bleeding tendency, or thrombolytic/anticoagulant therapy (except prophylaxis)
- Significant bleeding within 3 months (e.g., hemoptysis ≥ 2.5 mL, GI bleeding, varices, ulcers, vasculitis)
- Known hereditary/acquired bleeding or thrombotic disorders (e.g., hemophilia, thrombocytopenia)
- History of substance abuse or mental disorders affecting compliance
- Use of warfarin or coumarin derivatives within 14 days before or during treatment
- Other severe acute/chronic conditions increasing risk or confounding results
- Poor compliance or other conditions deemed unsuitable for trial participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 201805
Hao Shen, Dr, +8616628552926, shenhaochina@163.com
Hao, shenhaochina@163.com
About this study
Official title: The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD Background: a Dual Arm, Multicenter, Randomized Controlled Study
This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.
Read the detailed description
The study will recruit 20 patients, randomly dividing them into sequential and concurrent groups for up to 6 months of treatment and follow-up. In addition to routine efficacy assessments, the study will analyze changes in the microenvironment before and after treatment, including T-cell calcium levels, VEGFA expression, and immune-related factor alterations. Furthermore, it will explore the relationship between T-cell calcium signaling genes and treatment response, evaluating the impact of baseline metabolic characteristics (such as blood lipids and insulin resistance) on therapeutic outcomes.
In terms of safety, the study will monitor all adverse events (AEs) and serious adverse events (SAEs), and classify them according to the CTCAE 5.0 criteria. During the treatment period, patients will undergo regular liver biopsy to assess changes in the tumor microenvironment. The ultimate goal of the study is to provide evidence-based precision treatment strategies for MASLD-HCC patients.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- Sequential treatment of bevacizumab combined with atezolizumab (sequential group), Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)
- Keywords
- MASH, HCC, immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential treatment of bevacizumab combined with atezolizumab (sequential group)Drug
The first cycle (3 weeks) receives bevacizumab monotherapy, and from the second cycle onwards, it is combined with atezolizumab until disease progression or intolerable toxicity.
Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)Drug
Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)
| Study group | Role | What they receive |
|---|---|---|
| Sequential treatment of bevacizumab combined with atezolizumab (sequential group) | Experimental | Sequential treatment of bevacizumab combined with atezolizumab (sequential group) Receives: Drug: Sequential treatment of bevacizumab combined with atezolizumab (sequential group) |
| Simultaneous treatment of bevacizumab combined with atezolizumab (same period group) | Active comparator | Simultaneous treatment of bevacizumab combined with atezolizumab (same period group) Receives: Drug: Simultaneous treatment of bevacizumab combined with atezolizumab (same period group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Compare the objective response rate (ORR) of sequential treatment with bevacizumab combined with atezolizumab (sequential group) and concurrent treatment (concurrent group) in advanced HCC under MASLD background, according to RECIST 1.1 criteria.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start20 Oct 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Although this study investigates the role of sequential therapy, the experimental design involves two parallel groups. One group receives atezolizumab combined with bevacizumab, while the other group is treated first with bevacizumab followed by sequential administration of atezolizumab. Both groups receive the same drugs, differing only in the sequence of administration.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Feng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285850
- Sponsor's protocol ID
- EHBHKY2024-K023-P011
- Other IDs
- 82403243
- Acronym
- ABATE-MASLD
- Status last verified
- Dec 2025
- First submitted
- 17 Aug 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD Background: a Dual Arm, Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07285850
- Acronym / sponsor ID
- ABATE-MASLD / EHBHKY2024-K023-P011
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- MASH, HCC, immunotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 16 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 research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.
Detailed description
The study will recruit 20 patients, randomly dividing them into sequential and concurrent groups for up to 6 months of treatment and follow-up. In addition to routine efficacy assessments, the study will analyze changes in the microenvironment before and after treatment, including T-cell calcium levels, VEGFA expression, and immune-related factor alterations. Furthermore, it will explore the relationship between T-cell calcium signaling genes and treatment response, evaluating the impact of baseline metabolic characteristics (such as blood lipids and insulin resistance) on therapeutic outcomes.
In terms of safety, the study will monitor all adverse events (AEs) and serious adverse events (SAEs), and classify them according to the CTCAE 5.0 criteria. During the treatment period, patients will undergo regular liver biopsy to assess changes in the tumor microenvironment. The ultimate goal of the study is to provide evidence-based precision treatment strategies for MASLD-HCC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Although this study investigates the role of sequential therapy, the experimental design involves two parallel groups. One group receives atezolizumab combined with bevacizumab, while the other group is treated first with bevacizumab followed by sequential administration of atezolizumab. Both groups receive the same drugs, differing only in the sequence of administration.
| Arm | Type | Receives |
|---|---|---|
| Sequential treatment of bevacizumab combined with atezolizumab (sequential group) | Experimental | Drug: Sequential treatment of bevacizumab combined with atezolizumab (sequential group)Sequential treatment of bevacizumab combined with atezolizumab (sequential group) |
| Simultaneous treatment of bevacizumab combined with atezolizumab (same period group) | Active comparator | Drug: Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)Simultaneous treatment of bevacizumab combined with atezolizumab (same period group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (25 listed)
- Excessive alcohol consumption (weekly ethanol intake: males < 210 g, females < 140 g)
- Tumor lesions previously treated with targeted therapy, immunotherapy, TACE, or radiotherapy
- Pregnant or breastfeeding women, or positive pregnancy test at baseline
- Central nervous system metastases diagnosed by CT, MRI, or PET-CT
- Participation in another clinical drug or therapy trial within 4 weeks before first study dose
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 |
|---|---|---|
| Sequential treatment of bevacizumab combined with atezolizumab (sequential group)The first cycle (3 weeks) receives bevacizumab monotherapy, and from the second cycle onwards, it is combined with atezolizumab until disease progression or intolerable toxicity. | Drug | Sequential treatment of bevacizumab combined with atezolizumab (sequential group) |
| Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)Simultaneous treatment of bevacizumab combined with atezolizumab (same period group) | Drug | Simultaneous treatment of bevacizumab combined with atezolizumab (same period group) |
Primary outcome
objective response rate (ORR)
Time frame: 6 Months
Compare the objective response rate (ORR) of sequential treatment with bevacizumab combined with atezolizumab (sequential group) and concurrent treatment (concurrent group) in advanced HCC under MASLD background, according to RECIST 1.1 criteria.
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 16 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sequential treatment of bevacizumab combined with atezolizumab (sequential group) and Simultaneous treatment of bevacizumab combined with atezolizumab (same period group) in people with HCC - Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery 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 0 inclusion and 25 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 16 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Hao Shen, M.D. (18952681068, shenhaochina@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (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 16 Dec 2025.