Hepatocellular CarcinomaNCT07281664
Transarterial Chemoembolization With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hepatocellular Carcinoma
A study testing Transarterial chemoembolization (TACE) and bevacizumab and atezolizumab in people with Hepatocellular Carcinoma and Transarterial Chemoembolization, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial summary
This study aims to evaluate the safety and effectiveness of a combined treatment for patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Transarterial Chemoembolization
- What is being tested?
- Transarterial chemoembolization (TACE) and bevacizumab and atezolizumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2029
- 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
- Age between18 and 75 years;
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Child-Pugh class A;
- Eastern Cooperative Group performance status (ECOG) score of 0-1;
- No prior systemic therapy for HCC.
- Adequate hematologic and end-organ function;
- At least one measurable intrahepatic target lesion.
Who cannot join
- Diffuse HCC;
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible;
- Evidence of extrahepatic spread (EHS);
- Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;
- Evidence or history of bleeding diathesis or any hemorrhage or bleeding event >CTCAE grade 3 within 4 weeks prior to randomization;
- Active or history of autoimmune disease or immune deficiency;
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- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding;
- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment;
- Evidence of bleeding diathesis or significant coagulopathy;
- Pregnant or breastfeeding females;
- Significant cardiovascular disease;
- Severe infection, such as active tuberculosis;
- Serious medical comorbidities;
- History of organ or cells transplantation;
- History of other uncurable malignancies.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transarterial Chemoembolization Combined With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Phase II, Single-Arm Clinical Trial
This study aims to evaluate the safety and effectiveness of a combined treatment for patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. The treatment includes transarterial chemoembolization (TACE), which delivers chemotherapy directly into the liver tumor, together with low-dose bevacizumab and atezolizumab, two medicines that help the immune system fight cancer and inhibit tumor blood vessel growth.
All participants in this study will receive the same combination treatment as their first-line therapy. The study will observe how well the tumor responds, how long the treatment can control the cancer, and what side effects may occur. The goal is to learn whether this combined approach can provide clinical benefit and improve outcomes for patients with advanced, unresectable liver cancer.
Read the detailed description
Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage, when surgical treatment is no longer possible. Transarterial chemoembolization (TACE) is widely used for locoregional control, but many patients eventually experience tumor progression due to treatment-related hypoxia and activation of pro-angiogenic pathways. Combining TACE with systemic therapies that block angiogenesis and enhance antitumor immunity may help overcome these limitations.
Bevacizumab, an anti-VEGF antibody, reduces tumor angiogenesis and may counteract the surge in VEGF that occurs after TACE. Atezolizumab, an immune checkpoint inhibitor, strengthens the immune response against cancer cells. Using low-dose bevacizumab together with atezolizumab may help maximize immunotherapy benefit while minimizing toxicity, especially when administered after TACE.
This single-arm Phase II study is designed to investigate whether integrating TACE with low-dose bevacizumab and atezolizumab as first-line treatment can improve clinical outcomes in patients with unresectable HCC. The study will evaluate tumor control, treatment duration, and safety in real-world clinical settings. The findings may provide evidence to support a multimodal treatment strategy that targets both the tumor vasculature and the immune microenvironment, potentially offering a more effective option for patients with advanced liver cancer.
- Being tested
- Transarterial chemoembolization (TACE), bevacizumab and atezolizumab
- Keywords
- Hepatocellular Carcinoma, Transarterial chemoembolization, Bevacizumab, 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.
Transarterial chemoembolization (TACE)Procedure or surgery
The intervention consisted of TACE combined with low-dose bevacizumab and atezolizumab. TACE was performed within 30 days before or after systemic therapy. The choice between conventional TACE and DEB-TACE was determined by interventional radiologists, as both techniques show comparable efficacy. For DEB-TACE, epirubicin-loaded microspheres were used; for conventional TACE, an epirubicin-lipiodol emulsion was prepared. In all cases, the tumor-feeding artery was super-selectively catheterized, and embolization was performed to complete arterial stasis using gelatin sponge particles.
Following TACE-induced ischemic and cytotoxic tumor control, patients received systemic therapy consisting of low-dose bevacizumab to attenuate post-TACE angiogenic rebound and atezolizumab to enhance antitumor immune activation. This sequential combination of locoregional therapy and dual-agent systemic therapy constitutes a distinct intervention compared with standard TACE or systemic therapy alone.
bevacizumab and atezolizumabDrug
Low dose bevacizumab and atezolizumab
| Study group | Role | What they receive |
|---|---|---|
| TACE + LDBev + Atezo | Experimental | Participants in this single-arm study will receive a combination treatment consisting of transarterial chemoembolization (TACE) followed by systemic therapy with low-dose bevacizumab and atezolizumab. TACE will be performed as the locoregional therapy to control intrahepatic tumors, after which bevacizumab and atezolizumab will be administered to inhibit angiogenesis and enhance antitumor immune activity. All participants will be treated according to the study protocol to evaluate the safety and clinical activity of this integrated therapeutic approach for unresectable hepatocellular carcinoma. Receives: Procedure: Transarterial chemoembolization (TACE); Drug: bevacizumab and atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Time from randomization to death from any cause.
Measured: 2 years
Secondary outcomes (1)
Progression free survival (PFS)
Time from randomization to disease progression (mRECIST) or death from any cause, whichever occurred first.
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 posted15 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Mingsheng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Mingsheng Huang, M.D. & Ph.D, Principal investigator, Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281664
- Sponsor's protocol ID
- II2025-380-01
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) may be shared upon reasonable request. Any data sharing will be discussed and agreed upon with the corresponding author to ensure that it complies with ethical, regulatory, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Chemoembolization Combined With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Phase II, Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07281664
- Acronym / sponsor ID
- II2025-380-01
- Keywords
- Hepatocellular Carcinoma, Transarterial chemoembolization, Bevacizumab, Atezolizumab
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 15 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 study aims to evaluate the safety and effectiveness of a combined treatment for patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. The treatment includes transarterial chemoembolization (TACE), which delivers chemotherapy directly into the liver tumor, together with low-dose bevacizumab and atezolizumab, two medicines that help the immune system fight cancer and inhibit tumor blood vessel growth.
All participants in this study will receive the same combination treatment as their first-line therapy. The study will observe how well the tumor responds, how long the treatment can control the cancer, and what side effects may occur. The goal is to learn whether this combined approach can provide clinical benefit and improve outcomes for patients with advanced, unresectable liver cancer.
Detailed description
Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage, when surgical treatment is no longer possible. Transarterial chemoembolization (TACE) is widely used for locoregional control, but many patients eventually experience tumor progression due to treatment-related hypoxia and activation of pro-angiogenic pathways. Combining TACE with systemic therapies that block angiogenesis and enhance antitumor immunity may help overcome these limitations.
Bevacizumab, an anti-VEGF antibody, reduces tumor angiogenesis and may counteract the surge in VEGF that occurs after TACE. Atezolizumab, an immune checkpoint inhibitor, strengthens the immune response against cancer cells. Using low-dose bevacizumab together with atezolizumab may help maximize immunotherapy benefit while minimizing toxicity, especially when administered after TACE.
This single-arm Phase II study is designed to investigate whether integrating TACE with low-dose bevacizumab and atezolizumab as first-line treatment can improve clinical outcomes in patients with unresectable HCC. The study will evaluate tumor control, treatment duration, and safety in real-world clinical settings. The findings may provide evidence to support a multimodal treatment strategy that targets both the tumor vasculature and the immune microenvironment, potentially offering a more effective option for patients with advanced liver cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE + LDBev + Atezo | Experimental | Procedure: Transarterial chemoembolization (TACE), Drug: bevacizumab and atezolizumabParticipants in this single-arm study will receive a combination treatment consisting of transarterial chemoembolization (TACE) followed by systemic therapy with low-dose bevacizumab and atezolizumab. TACE will be performed as the locoregional therapy to control intrahepatic tumors, after which bevacizumab and atezolizumab will be administered to inhibit angiogenesis and enhance antitumor immune activity. All participants will be treated according to the study protocol to evaluate the safety and clinical activity of this integrated therapeutic approach for unresectable hepatocellular carcinoma. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between18 and 75 years;
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Child-Pugh class A;
- Eastern Cooperative Group performance status (ECOG) score of 0-1;
- No prior systemic therapy for HCC.
Key exclusion criteria (15 listed)
- Diffuse HCC;
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible;
- Evidence of extrahepatic spread (EHS);
- Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;
- Evidence or history of bleeding diathesis or any hemorrhage or bleeding event >CTCAE grade 3 within 4 weeks prior to randomization;
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 |
|---|---|---|
| Transarterial chemoembolization (TACE)The intervention consisted of TACE combined with low-dose bevacizumab and atezolizumab. TACE was performed within 30 days before or after systemic therapy. The choice between conventional TACE and DEB-TACE was determined by interventional radiologists, as both techniques show comparable efficacy. For DEB-TACE, epirubicin-loaded microspheres were used; for conventional TACE, an epirubicin-lipiodol emulsion was prepared. In all cases, the tumor-feeding artery was super-selectively catheterized, and embolization was performed to complete arterial stasis using gelatin sponge particles. Following TACE-induced ischemic and cytotoxic tumor control, patients received systemic therapy consisting of low-dose bevacizumab to attenuate post-TACE angiogenic rebound and atezolizumab to enhance antitumor immune activation. This sequential combination of locoregional therapy and dual-agent systemic therapy constitutes a distinct intervention compared with standard TACE or systemic therapy alone. | Procedure or surgery | TACE + LDBev + Atezo |
| bevacizumab and atezolizumabLow dose bevacizumab and atezolizumab | Drug | TACE + LDBev + Atezo |
Primary outcome
Overall survival (OS)
Time frame: 2 years
Time from randomization to death from any cause.
1 secondary outcome
Progression free survival (PFS)
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 15 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) may be shared upon reasonable request. Any data sharing will be discussed and agreed upon with the corresponding author to ensure that it complies with ethical, regulatory, and institutional requirements.
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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.
Mingsheng Huang, M.D. & Ph.D principal investigator
Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing Transarterial chemoembolization (TACE) and bevacizumab and atezolizumab in people with Hepatocellular Carcinoma and Transarterial Chemoembolization, run by Third Affiliated Hospital, Sun Yat-Sen University.
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 15 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: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mingsheng Huang, M.D. & Ph.D (+862085253416, huangmsh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 2 years). 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 15 Dec 2025.