Hepatocellular CarcinomaNCT07543510
Low-Dose Bevacizumab and Atezolizumab Combined With TACE-HAIC in Unresectable Hepatocellular Carcinoma
A study testing TACE-HAIC + Atezolizumab + Low-dose Bevacizumab in people with Hepatocellular Carcinoma and Atezolizumab Plus Bevacizumab, run by Third Affiliated Hospital, Sun Yat-Sen University.
Trial summary
This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of low-dose bevacizumab plus atezolizumab combined with transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) as first-line treatment for patients with unresectable… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Atezolizumab Plus Bevacizumab, Transarterial Chemoembolization
- What is being tested?
- TACE-HAIC + Atezolizumab + Low-dose Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily provides written informed consent. Age ≥18 years. Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or clinically diagnosed HCC in patients with cirrhosis according to AASLD criteria.
- Unresectable HCC suitable for TACE treatment, including BCLC stage B or C, without Vp4 portal vein tumor thrombus or extrahepatic metastasis.
- No prior systemic therapy for HCC. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Child-Pugh class A or class B7 liver function. No history of autoimmune disease. Life expectancy of at least 3 months. At least one measurable lesion according to RECIST v1.1.
- Adequate hematologic, hepatic, and renal function within 1 week before enrollment:
- Neutrophils ≥1.5 × 10^9/L Platelets ≥50 × 10^9/L Hemoglobin ≥90 g/L ALT and AST ≤5 × upper limit of normal (ULN) Serum creatinine ≤1.5 × ULN INR <2.3, or prothrombin time ≤ULN + 6 seconds Albumin ≥30 g/L Total bilirubin ≤3 × ULN Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment, must not be breastfeeding, and must agree to use effective contraception during the study and for 6 months after the end of study treatment. Men must also agree to use effective contraception during the study and for 6 months after the end of study treatment.
Who cannot join
- Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma; or other active malignancy within 5 years, except adequately treated localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast.
- Severe allergy to iodinated contrast agents that precludes TACE-HAIC treatment. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 1 month before enrollment.
- Active infection that cannot be effectively controlled. Severe gastroesophageal varices, or untreated/incompletely treated varices with bleeding or high bleeding risk.
- Brain metastases or bone metastases requiring urgent surgical or radiotherapeutic intervention.
- Pregnancy, suspected pregnancy, or breastfeeding. Current use of, or recent use within 10 days before study treatment of, aspirin >325 mg/day, dipyridamole, ticlopidine, clopidogrel, or cilostazol.
- Thrombotic or embolic events within 6 months before treatment initiation, including cerebrovascular accident, transient ischemic attack, cerebral hemorrhage, cerebral infarction, or pulmonary embolism.
- Congenital or acquired immunodeficiency. Any of the following within 12 months before study start: myocardial infarction, severe or unstable angina, or congestive heart failure.
- Renal failure requiring dialysis. Prior organ transplantation. Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality, that may increase study risk, interfere with interpretation of results, or make the patient unsuitable for enrollment in the investigator's judgment.
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: Efficacy and Safety of Low-Dose Bevacizumab and Atezolizumab Combined With Transarterial Chemoembolization Sequential Hepatic Arterial Infusion Chemotherapy as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Single-Arm, Phase II Trial
This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of low-dose bevacizumab plus atezolizumab combined with transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). The study plans to enroll approximately 38 patients with unresectable, locally advanced HCC who have not received prior systemic therapy.
Although atezolizumab plus bevacizumab has become a standard first-line treatment option for advanced HCC, the objective response rate remains limited. TACE-HAIC may improve tumor control by increasing local chemotherapy exposure, promoting tumor antigen release, and enhancing the anti-tumor activity of immunotherapy and anti-angiogenic therapy. In this study, patients will receive TACE-HAIC in combination with atezolizumab and low-dose bevacizumab, followed by maintenance treatment with atezolizumab plus low-dose bevacizumab until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria.
The primary endpoint is objective response rate (ORR) assessed by investigators according to RECIST version 1.1. Secondary endpoints include ORR by mRECIST, disease control rate, duration of response, progression-free survival, time to progression, overall survival, and safety. This study aims to explore whether this combination strategy can provide improved anti-tumor activity with manageable safety in patients with unresectable HCC.
- Being tested
- TACE-HAIC + Atezolizumab + Low-dose Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE-HAIC + Atezolizumab + Low-dose BevacizumabDrug
Participants with unresectable hepatocellular carcinoma (HCC) receive first-line treatment with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen, administered via hepatic artery catheter. The HAIC regimen consists of oxaliplatin 85 mg/m² by arterial infusion over 2 hours on Day 1, followed by leucovorin 400 mg/m² by arterial infusion over 1 hour on Day 1, then fluorouracil 400 mg/m² bolus infusion and 2400 mg/m² continuous infusion over 24 hours. Subsequently, participants receive intravenous atezolizumab (1200 mg fixed dose, every 3 weeks) and low-dose bevacizumab (7.5 mg/kg, every 3 weeks). Each treatment cycle is 21 days. Treatment continues until disease progression according to RECIST v1.1, unacceptable toxicity, withdrawal of consent, conversion to resectable disease, or other protocol-defined discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| TACE-HAIC + Atezolizumab + Low-dose Bevacizumab | Experimental | Participants with unresectable hepatocellular carcinoma who have not received prior systemic therapy will be enrolled into a single treatment cohort. All participants will receive transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) in combination with atezolizumab and low-dose bevacizumab as first-line treatment. Atezolizumab will be administered at a fixed dose of 1200 mg intravenously every 3 weeks, and bevacizumab will be administered at 7.5 mg/kg intravenously every 3 weeks. HAIC will be given using the FOLFOX regimen, and subsequent TACE will be performed as needed according to the patient's condition and investigator judgment. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, conversion to resectable disease, or other protocol-defined discontinuation criteria. Receives: Drug: TACE-HAIC + Atezolizumab + Low-dose Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of participants achieving complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST v1.1 criteria, assessed by the investigator.
Measured: 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 criteria or death from any cause, whichever occurs first, as assessed by the investigator.
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 posted22 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543510
- Sponsor's protocol ID
- II2026-114-01
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 22 Apr 2026
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-Dose Bevacizumab and Atezolizumab Combined With Transarterial Chemoembolization Sequential Hepatic Arterial Infusion Chemotherapy as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Single-Arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT07543510
- Acronym / sponsor ID
- II2026-114-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 22 Apr 2026 (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 prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of low-dose bevacizumab plus atezolizumab combined with transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). The study plans to enroll approximately 38 patients with unresectable, locally advanced HCC who have not received prior systemic therapy.
Although atezolizumab plus bevacizumab has become a standard first-line treatment option for advanced HCC, the objective response rate remains limited. TACE-HAIC may improve tumor control by increasing local chemotherapy exposure, promoting tumor antigen release, and enhancing the anti-tumor activity of immunotherapy and anti-angiogenic therapy. In this study, patients will receive TACE-HAIC in combination with atezolizumab and low-dose bevacizumab, followed by maintenance treatment with atezolizumab plus low-dose bevacizumab until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria.
The primary endpoint is objective response rate (ORR) assessed by investigators according to RECIST version 1.1. Secondary endpoints include ORR by mRECIST, disease control rate, duration of response, progression-free survival, time to progression, overall survival, and safety. This study aims to explore whether this combination strategy can provide improved anti-tumor activity with manageable safety in patients with unresectable HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE-HAIC + Atezolizumab + Low-dose Bevacizumab | Experimental | Drug: TACE-HAIC + Atezolizumab + Low-dose BevacizumabParticipants with unresectable hepatocellular carcinoma who have not received prior systemic therapy will be enrolled into a single treatment cohort. All participants will receive transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) in combination with atezolizumab and low-dose bevacizumab as first-line treatment. Atezolizumab will be administered at a fixed dose of 1200 mg intravenously every 3 weeks, and bevacizumab will be administered at 7.5 mg/kg intravenously every 3 weeks. HAIC will be given using the FOLFOX regimen, and subsequent TACE will be performed as needed according to the patient's condition and investigator judgment. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, conversion to resectable disease, or other protocol-defined discontinuation criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily provides written informed consent. Age ≥18 years. Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or clinically diagnosed HCC in patients with cirrhosis according to AASLD criteria.
- Unresectable HCC suitable for TACE treatment, including BCLC stage B or C, without Vp4 portal vein tumor thrombus or extrahepatic metastasis.
- No prior systemic therapy for HCC. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Child-Pugh class A or class B7 liver function. No history of autoimmune disease. Life expectancy of at least 3 months. At least one measurable lesion according to RECIST v1.1.
- Neutrophils ≥1.5 × 10^9/L Platelets ≥50 × 10^9/L Hemoglobin ≥90 g/L ALT and AST ≤5 × upper limit of normal (ULN) Serum creatinine ≤1.5 × ULN INR <2.3, or prothrombin time ≤ULN + 6 seconds Albumin ≥30 g/L Total bilirubin ≤3 × ULN Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment, must not be breastfeeding, and must agree to use effective contraception during the study and for 6 months after the end of study treatment. Men must also agree to use effective contraception during the study and for 6 months after the end of study treatment.
Key exclusion criteria (8 listed)
- Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma; or other active malignancy within 5 years, except adequately treated localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast.
- Severe allergy to iodinated contrast agents that precludes TACE-HAIC treatment. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 1 month before enrollment.
- Active infection that cannot be effectively controlled. Severe gastroesophageal varices, or untreated/incompletely treated varices with bleeding or high bleeding risk.
- Brain metastases or bone metastases requiring urgent surgical or radiotherapeutic intervention.
- Pregnancy, suspected pregnancy, or breastfeeding. Current use of, or recent use within 10 days before study treatment of, aspirin >325 mg/day, dipyridamole, ticlopidine, clopidogrel, or cilostazol.
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 |
|---|---|---|
| TACE-HAIC + Atezolizumab + Low-dose BevacizumabParticipants with unresectable hepatocellular carcinoma (HCC) receive first-line treatment with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen, administered via hepatic artery catheter. The HAIC regimen consists of oxaliplatin 85 mg/m² by arterial infusion over 2 hours on Day 1, followed by leucovorin 400 mg/m² by arterial infusion over 1 hour on Day 1, then fluorouracil 400 mg/m² bolus infusion and 2400 mg/m² continuous infusion over 24 hours. Subsequently, participants receive intravenous atezolizumab (1200 mg fixed dose, every 3 weeks) and low-dose bevacizumab (7.5 mg/kg, every 3 weeks). Each treatment cycle is 21 days. Treatment continues until disease progression according to RECIST v1.1, unacceptable toxicity, withdrawal of consent, conversion to resectable disease, or other protocol-defined discontinuation criteria. | Drug | TACE-HAIC + Atezolizumab + Low-dose Bevacizumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years
Percentage of participants achieving complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST v1.1 criteria, assessed by the investigator.
Progression-Free Survival (PFS)
Time frame: 2 years
PFS is defined as the time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 criteria or death from any cause, whichever occurs first, as assessed by the investigator.
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 22 Apr 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing TACE-HAIC + Atezolizumab + Low-dose Bevacizumab in people with Hepatocellular Carcinoma and Atezolizumab Plus Bevacizumab, 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 5 inclusion and 8 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 22 Apr 2026. 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 (86-20-85253416, 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?
Objective Response Rate (ORR) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 22 Apr 2026.