Hepatocellular CarcinomaPhase 3NCT07594340
HAIC vs. TACE Combined With Sintilimab and Bevacizumab for Intermediate HCC (Beyond Up-To-Seven)
A Phase 3 study testing Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks. and TACE (transarterial chemoembolization) combined with targeted/immunotherapy in people with Hepatocellular Carcinoma, run by Binkui Li at 1 site in China.
Trial summary
The purpose of this prospective, randomized, multicenter, controlled clinical study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared to transarterial chemoembolization (TACE) when both are combined with sintilimab and bevacizumab for patients with intermediate-stage… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks. and TACE (transarterial chemoembolization) combined with targeted/immunotherapy
- 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
- 15 May 2026to 30 May 2030
- Phase
- Phase 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or patients with cirrhosis meeting the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC.
- Age: ≥ 18 years old.
- Performance Status: ECOG performance status score of 0.
- Prior Treatment: No prior systemic anti-tumor therapy or transarterial interventional therapy for HCC.
- Tumor Stage and Burden: Barcelona Clinic Liver Cancer (BCLC) Stage B, unsuitable for radical surgery and/or local therapy (such as ablation).
- Up-To-Seven Criteria: Tumor burden exceeding the Up-To-Seven criteria, defined as the sum of the size of the largest intrahepatic tumor (in cm) and the number of tumors being greater than 7.
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- Tumor Distribution: Bilobar multifocal tumors.
- Measurable Disease: At least one measurable lesion with arterial phase enhancement on CT/MRI.
- Vascular Status: Patent portal vein with no evidence of portal vein tumor thrombus.
- Extrahepatic Status: No extrahepatic metastasis.
- Variceal Risk: No risk of variceal bleeding; esophagogastroduodenoscopy (EGD) within 6 months shows no gastroesophageal varices or active ulcers.
- Liver Function: Child-Pugh Grade A.
- Hematology: Platelets > 75 × 10⁹/L; White Blood Cells > 3.0 × 10⁹/L; Neutrophils > 1.5 × 10⁹/L.
- Biochemistry: Serum bilirubin ≤ 1.5 × upper limit of normal (ULN); Transaminases ≤ 3 × ULN; Serum creatinine < 1.5 × ULN.
- Physical Findings: No ascites
- Albumin ≥ 30 g/L.
- Coagulation: Normal coagulation function.
- Expectancy: Expected survival > 3 months.
- Consent: Signed written informed consent and willingness/ability to comply with follow-up until death, study completion, or termination.
Who cannot join
- Histology: Known histology/cytology of fibrolamellar HCC, sarcomatoid HCC, or components of cholangiocarcinoma.
- Medical History: History of hepatic encephalopathy or liver transplantation.
- Effusions: Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.
- Viral Hepatitis: Active Hepatitis B (HBV DNA > 2000 IU/ml or 10⁴ copies/ml) or Hepatitis C (HCV RNA > 10³ copies/ml); co-infection with both HBsAg and anti-HCV positive. (Eligible if levels drop below these criteria after nucleoside antiviral therapy) .
- Cardiovascular (Past 12 Months): Myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), or pulmonary embolism.
- Ongoing Cardiac Issues: Arrhythmia ≥ Grade 2 (NCI-CTCAE); QTc prolongation (Male > 450 ms, Female > 470 ms).
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- Bleeding Risk: History of gastrointestinal bleeding within 6 months or clear bleeding tendency (e.g., high-risk varices, active GI ulcer, persistent positive fecal occult blood).
- Hypertension: Uncontrollable hypertension (SBP > 140 mmHg or DBP > 90 mmHg despite optimal treatment); history of hypertensive crisis or hypertensive encephalopathy.
- Organ Failure: Renal failure requiring hemodialysis or peritoneal dialysis; severe dysfunction of other major organs.
- Second Malignancy: History of other malignancies within 3 years prior to screening (except those with negligible risk of metastasis/death such as treated cervical cancer in situ, non-melanoma skin cancer, or localized prostate cancer).
- CNS Involvement: Known or new evidence of brain or leptomeningeal lesions. Coagulation Disorders: Hemophilia or bleeding tendency; currently taking therapeutic doses of coumarin derivatives (e.g., warfarin).
- Pregnancy/Lactation: Pregnant or breastfeeding females; women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
- Other History: Prior organ transplant; known HIV infection; active tuberculosis; allergy to chemotherapy drugs.
- Autoimmune Diseases: Active or history of autoimmune diseases (e.g., myasthenia gravis, myositis, autoimmune hepatitis, SLE, rheumatoid arthritis, IBD, etc.).
- General Compliance: Any serious acute/chronic physical or mental illness, or laboratory abnormalities that increase study risk or interfere with interpretation of results.
- Non-compliance: History of significant non-compliance with medical protocols or inability to provide reliable informed consent.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Wei He, 15521248313, hewei@sysucc.org.cn
Binkui Li
About this study
Official title: Hepatic Arterial Infusion Chemotherapy Plus Sintilimab and Bevacizumab Versus Transarterial Chemoembolization Plus Sintilimab and Bevacizumab for Intermediate-Stage Hepatocellular Carcinoma Beyond the Up-To-Seven Criteria：A Prospective, Randomized, Controlled Trial
The purpose of this prospective, randomized, multicenter, controlled clinical study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared to transarterial chemoembolization (TACE) when both are combined with sintilimab and bevacizumab for patients with intermediate-stage hepatocellular carcinoma (HCC). Specifically, the trial focuses on patients with a high tumor burden that exceeds the Up-To-Seven criteria.While TACE is the standard treatment for BCLC stage B HCC, its effectiveness is often limited in patients with extensive intrahepatic tumor loads. This study investigates whether the combination of FOLFOX-HAIC and systemic therapy (sintilimab plus bevacizumab) provides better local control and survival outcomes than the combination of TACE and the same systemic therapy.
Experimental Group: Patients receive FOLFOX-HAIC (up to 4 cycles in the first 16 weeks) combined with sintilimab and bevacizumab. Control Group: Patients receive on-demand TACE (up to 4 cycles in the first 16 weeks) combined with sintilimab and bevacizumab. Primary Objective: To compare Progression-Free Survival (PFS) between the two arms as evaluated by mRECIST. Enrollment: A total of 300 patients will be randomized at a 1:1 ratio to the treatment groups. The study aims to provide high-level clinical evidence for optimizing treatment strategies for this specific subgroup of HCC patients.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks., TACE (transarterial chemoembolization) combined with targeted/immunotherapy
- Keywords
- hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks.Procedure or surgery
Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks. Oxaliplatin: 130mg/m² infusion (2h). Leucovorin: 400mg/m² infusion (2h). 5-FU: 400mg/m² bolus (10min) + 1200mg/m² infusion (23h).
TACE (transarterial chemoembolization) combined with targeted/immunotherapyProcedure or surgery
Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (TACE): On-demand (max 4 cycles within 16 weeks). Epirubicin (30mg/m²) + Lobaplatin (30-50mg) + Lipiodol (5-20ml).
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX-HAIC Combination | Experimental | Intervention:
Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks. Oxaliplatin: 130mg/m² infusion (2h). Leucovorin: 400mg/m² infusion (2h). 5-FU: 400mg/m² bolus (10min) + 1200mg/m² infusion (23h). Receives: Procedure: Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks. |
| TACE Combination | Active comparator | Intervention:
Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (TACE): On-demand (max 4 cycles within 16 weeks). Epirubicin (30mg/m²) + Lobaplatin (30-50mg) + Lipiodol (5-20ml). Receives: Procedure: TACE (transarterial chemoembolization) combined with targeted/immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Progression-Free Survival (PFS): From randomization to first documentation of progression (mRECIST) or death from any cause.
Measured: From date of randomization until the date of first documented progression (per mRECIST) or date of death from any cause, assessed up to 5 years.
Secondary outcomes (8)
Overall Survival
Overall Survival (OS): From randomization to death from any cause.
Measured: From date of randomization until the date of death from any cause, assessed up to 5 years.
Objective Response Rate
Objective Response Rate (ORR): Proportion of patients with CR or PR per mRECIST and RECIST 1.1.
Measured: From date of randomization until the end of systemic treatment (up to 12 months).
Disease Control Rate
Disease Control Rate (DCR): Proportion of patients with CR, PR, or SD.
Measured: From date of randomization until the end of systemic treatment (up to 12 months).
Duration of Response
From initial response (CR or PR) to the date of first documented progression or death
Measured: From initial response (CR or PR) to the date of first documented progression or death，assessed up to 5 years.
Time to Progression
From date of randomization to the date of first objective tumor progression
Measured: From date of randomization to the date of first objective tumor progression, assessed up to 5 years.
Conversion Rate
Conversion Rate: Percentage of patients achieving surgical resection eligibility.
Measured: From date of randomization until the end of the conversion therapy assessment (typically within 12 months).
Safety Profile
Safety Profile: Incidence of adverse events per NCI CTCAE v5.0.
Measured: From randomization until 1 year after the last dose of study treatment.
Patient-Reported Outcomes
Patient-Reported Outcomes (PRO): Quality of life using IL42-EORTC QLQ-C30.
Measured: Baseline and every 1 month until the end of month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start15 May 2026 (estimated)
- Primary completion30 May 2030 (estimated)
- Study completion30 May 2030 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binkui Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Binkui Li, Sun Yat-sen University
- Investigators
- Binkui Li, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594340
- Sponsor's protocol ID
- B2026-143-01
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy Plus Sintilimab and Bevacizumab Versus Transarterial Chemoembolization Plus Sintilimab and Bevacizumab for Intermediate-Stage Hepatocellular Carcinoma Beyond the Up-To-Seven Criteria：A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07594340
- Acronym / sponsor ID
- B2026-143-01
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Binkui LiUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 May 2030 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 18 May 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.
The purpose of this prospective, randomized, multicenter, controlled clinical study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared to transarterial chemoembolization (TACE) when both are combined with sintilimab and bevacizumab for patients with intermediate-stage hepatocellular carcinoma (HCC). Specifically, the trial focuses on patients with a high tumor burden that exceeds the Up-To-Seven criteria.While TACE is the standard treatment for BCLC stage B HCC, its effectiveness is often limited in patients with extensive intrahepatic tumor loads. This study investigates whether the combination of FOLFOX-HAIC and systemic therapy (sintilimab plus bevacizumab) provides better local control and survival outcomes than the combination of TACE and the same systemic therapy.
Experimental Group: Patients receive FOLFOX-HAIC (up to 4 cycles in the first 16 weeks) combined with sintilimab and bevacizumab. Control Group: Patients receive on-demand TACE (up to 4 cycles in the first 16 weeks) combined with sintilimab and bevacizumab. Primary Objective: To compare Progression-Free Survival (PFS) between the two arms as evaluated by mRECIST. Enrollment: A total of 300 patients will be randomized at a 1:1 ratio to the treatment groups. The study aims to provide high-level clinical evidence for optimizing treatment strategies for this specific subgroup of HCC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOX-HAIC Combination | Experimental | Procedure: Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks.Intervention: Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks. Oxaliplatin: 130mg/m² infusion (2h). Leucovorin: 400mg/m² infusion (2h). 5-FU: 400mg/m² bolus (10min) + 1200mg/m² infusion (23h). |
| TACE Combination | Active comparator | Procedure: TACE (transarterial chemoembolization) combined with targeted/immunotherapyIntervention: Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (TACE): On-demand (max 4 cycles within 16 weeks). Epirubicin (30mg/m²) + Lobaplatin (30-50mg) + Lipiodol (5-20ml). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosis: Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or patients with cirrhosis meeting the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria for HCC.
- Age: ≥ 18 years old.
- Performance Status: ECOG performance status score of 0.
- Prior Treatment: No prior systemic anti-tumor therapy or transarterial interventional therapy for HCC.
- Tumor Stage and Burden: Barcelona Clinic Liver Cancer (BCLC) Stage B, unsuitable for radical surgery and/or local therapy (such as ablation).
Key exclusion criteria (16 listed)
- Histology: Known histology/cytology of fibrolamellar HCC, sarcomatoid HCC, or components of cholangiocarcinoma.
- Medical History: History of hepatic encephalopathy or liver transplantation.
- Effusions: Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.
- Viral Hepatitis: Active Hepatitis B (HBV DNA > 2000 IU/ml or 10⁴ copies/ml) or Hepatitis C (HCV RNA > 10³ copies/ml); co-infection with both HBsAg and anti-HCV positive. (Eligible if levels drop below these criteria after nucleoside antiviral therapy) .
- Cardiovascular (Past 12 Months): Myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), or pulmonary embolism.
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 |
|---|---|---|
| Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks.Drug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks. Oxaliplatin: 130mg/m² infusion (2h). Leucovorin: 400mg/m² infusion (2h). 5-FU: 400mg/m² bolus (10min) + 1200mg/m² infusion (23h). | Procedure or surgery | FOLFOX-HAIC Combination |
| TACE (transarterial chemoembolization) combined with targeted/immunotherapyDrug (Sintilimab): 200mg IV Q3W (Up to 12 months). Drug (Bevacizumab): 15mg/kg IV Q3W (Up to 12 months). Procedure (TACE): On-demand (max 4 cycles within 16 weeks). Epirubicin (30mg/m²) + Lobaplatin (30-50mg) + Lipiodol (5-20ml). | Procedure or surgery | TACE Combination |
Primary outcome
Progression-Free Survival
Time frame: From date of randomization until the date of first documented progression (per mRECIST) or date of death from any cause, assessed up to 5 years.
Progression-Free Survival (PFS): From randomization to first documentation of progression (mRECIST) or death from any cause.
8 secondary outcomes
Overall Survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years.
Objective Response Rate
Time frame: From date of randomization until the end of systemic treatment (up to 12 months).
Disease Control Rate
Time frame: From date of randomization until the end of systemic treatment (up to 12 months).
Duration of Response
Time frame: From initial response (CR or PR) to the date of first documented progression or death，assessed up to 5 years.
Time to Progression
Time frame: From date of randomization to the date of first objective tumor progression, assessed up to 5 years.
Conversion Rate
Time frame: From date of randomization until the end of the conversion therapy assessment (typically within 12 months).
Safety Profile
Time frame: From randomization until 1 year after the last dose of study treatment.
Patient-Reported Outcomes
Time frame: Baseline and every 1 month until the end of month 12.
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 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Binkui Li principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Procedure (FOLFOX-HAIC): Max 4 cycles within first 16 weeks. and TACE (transarterial chemoembolization) combined with targeted/immunotherapy in people with Hepatocellular Carcinoma, run by Binkui Li 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 19 inclusion and 16 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 22 May 2026. 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 phase mean?
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 Wei He (+8618666014207, hewei@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: From date of randomization until the date of first documented progression (per mRECIST) or date of death from any cause, assessed up to 5 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 22 May 2026.