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Advanced Hepatocellular Carcinoma (HCC)Phase 2HAIBrave-001NCT06737913

HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma

A Phase 2 study testing HAI Adebrelimab, intravenous infusion (IV) of Adebrelimab (ADE) and intravenous infusion (IV) of Bevacizumab (Bev.) in people with Advanced Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Adabrelimab (arterial or intravenous administration) combined with hepatic artery FOLFOX infusion chemotherapy and Bevacizumab as the first-line treatment of advanced stage hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Hepatocellular Carcinoma (HCC)
What is being tested?
HAI Adebrelimab, intravenous infusion (IV) of Adebrelimab (ADE) and intravenous infusion (IV) of Bevacizumab (Bev.)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
3 sitesChina
Study dates
3 Jan 2025to 31 Dec 2028
Phase
Phase 2
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 participate in the study and sign the informed consent form;
  • Aged ≥18 years (calculated as of the date of signing the informed consent form);
  • Diagnosed with hepatocellular carcinoma (HCC) by clinical or pathological means;
  • Barcelona Clinic Liver Cancer (BCLC) stage C, with vascular/bile duct invasion or distant metastasis (excluding cases with Vp4-type tumor thrombus);
  • No prior systemic therapy for HCC; or progression or residual lesions following prior local therapy for HCC (including but not limited to surgery, ablation, radiotherapy, or transarterial chemoembolization [TACE]), with an interval of at least one month between the last local treatment and enrollment;
  • ECOG Performance Status (PS) score of 0-1 and Child-Pugh grade A or grade B with a score of 7;
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  • No history of autoimmune disease;
  • An expected survival time of ≥3 months;
  • At least one measurable lesion (per RECIST v1.1 criteria, the longest diameter of the measurable lesion on spiral CT scan must be ≥10 mm or the short axis of enlarged lymph nodes must be ≥15 mm; lesions previously treated locally can be considered target lesions if progression is confirmed per RECIST v1.1 criteria);
  • Sufficient hematologic, hepatic, and renal function, with laboratory tests within the following parameters performed within one week prior to enrollment:
  • Neutrophil count ≥1.5×10^9/L;
  • Platelet count ≥75×10^9/L;
  • Hemoglobin ≥90 g/L;
  • Serum ALT and AST ≤5×upper limit of normal (ULN); ⑤ Serum creatinine ≤1.5×ULN; ⑥ International Normalized Ratio (INR) <2.3, or prothrombin time ≤ULN+6 seconds; ⑦ Albumin ≥30 g/L;
  • Total bilirubin ≤3×ULN.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within seven days prior to study enrollment, must not be breastfeeding, and must agree to use contraceptive measures during the study and for six months after its conclusion; men must agree to use contraceptive measures during the study and for six months after its conclusion.

Who cannot join

  • Patients with a severe allergy to iodine contrast agents who are unable to undergo hepatic arterial infusion chemotherapy (HAIC);
  • Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within one month prior to randomization;
  • Active infections that cannot be effectively controlled;
  • Severe gastroesophageal varices; untreated or incompletely treated gastroesophageal varices (with bleeding or high risk of bleeding);
  • Presence of brain metastases or bone metastases requiring urgent surgical or radiotherapy intervention;
  • Pregnant or suspected to be pregnant, or currently breastfeeding;
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  • Current use or recent use (within 10 days before the initiation of the study treatment) of aspirin (>325 mg/day, maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol;
  • Thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, or cerebral infarction) or pulmonary embolism, occurring within six months prior to the initiation of the study treatment;
  • Congenital or acquired immunodeficiency;
  • History of other malignant tumors;
  • Any of the following conditions within 12 months prior to the initiation of the study: myocardial infarction, severe/unstable angina, or congestive heart failure;
  • Renal insufficiency requiring dialysis;
  • History of organ transplantation;
  • Severe acute or chronic physical or mental illnesses or laboratory abnormalities that may increase study risks or interfere with result interpretation, rendering the patient unsuitable for enrollment.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lujun Shen, M.D. contact

86-13560365452

shenlj@sysucc.org.cn

China3 sites, 3 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510080

    Lujun Shen, M.D., +86-13560365452, shenlj@sysucc.org.cn

    Recruiting

  • Gansu Province Cancer Hospital

    Lanzhou, Gansu

    Xingdong Wang, M.D., +86-13609325641, lanhj@sysucc.org.cn

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Lin Zheng, M.D., +86-15838162655, hyzhenglin@163.com

    Recruiting

Other trials in China

About this study

Official title: Hepatic Arterial Infusion or Intravenous Infusion of Adebrelimab, Combined With Bevacizumab and Hepatic Arterial Infusion of FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma: a Multicenter, Open Label, Randomized Phase II Trial

The purpose of this study is to evaluate the efficacy and safety of Adabrelimab (arterial or intravenous administration) combined with hepatic artery FOLFOX infusion chemotherapy and Bevacizumab as the first-line treatment of advanced stage hepatocellular carcinoma. Patients will be randomized 1:1 etither to receive hepatic arterial infusion(HAI) Adabrelimab group or IV Adabrelimab group, and both groups will receive HAI FOLFOX chemotherapy and IV Bevacizumab.

Read the detailed description

The combination of anti-PD-L1 antibody and bevacizumab has been approved as the first-line treatment for advanced hepatocellular carcinoma (HCC). However, the overall response rate is still unsatisfactory and the prognosis of patients remains poor. Our previous retrospective analysis showed triple combination of hepatic arterial infusion chemotherapy (HAIC) of FOLFOX regimen plus adebrelimab (anti-PD-L1 antibody) and bevacizumab had a high response rate for advanced stage HCC patients. More, as the PD-L1 on intrahepatic tumors is the main target of anti-PD-L1 therapy, hepatic arterial infusion of anti-PD-L1 antibody may contribute to a synergistic effect. Herein, we aimed to evaluate the efficacy and safety of Adabrelimab (arterial or intravenous administration) combined with hepatic artery FOLFOX infusion chemotherapy and Bevacizumab as the first-line treatment of advanced stage hepatocellular carcinoma.

Being tested
HAI Adebrelimab, intravenous infusion (IV) of Adebrelimab (ADE), intravenous infusion (IV) of Bevacizumab (Bev.), HAIC with FOLFOX regimen, Adebrelimab and bevacizumab maintainance treatment
Keywords
Hepatic arterial infusion (HAI), hepatic arterial infusion of FOLFOX chemotherapy, advanced unresectable hepatocellular carcinoma (HCC), Adebrelimab (ADE), Bevacizumab (Bev.), intravenous infusion (IV)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAI AdebrelimabProcedure or surgery

    Also called HAI FOLFOX, IV Bevacizumab, IV Adebrelimab

    Hepatic arterial infusion (HAI) of Adebrelimab (ADE) (1200mg, IA, Q3W)

  • intravenous infusion (IV) of Adebrelimab (ADE)Drug

    intravenous infusion (IV) of Adebrelimab (ADE) (1200mg, IV, Q3W)

  • intravenous infusion (IV) of Bevacizumab (Bev.)Drug

    intravenous infusion (IV) of Bevacizumab (Bev.) (15mg/kg, IV, Q3W)

  • HAIC with FOLFOX regimenProcedure or surgery

    HAIC with FOLFOX regimen (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil bolus 400 mg/m2 on day 1, and 5-fluorouracil infusion 2500 mg/m2 for 46 hours via hepatic artery Q4W)

  • Adebrelimab and bevacizumab maintainance treatmentDrug

    The two arms continue the triple combination treatment up to 6 cycles and then received receive intravenous combination therapy of adebrelimab and bevacizumab for maintainance until disease progression or intolerable toxicity

Study groups in NCT06737913
Study groupRoleWhat they receive
HAIBrave-001 Arm 1ExperimentalArm 1 to receive Hepatic arterial infusion (HAI) of Adebrelimab (ADE) + intravenous infusion (IV) of Bevacizumab (Bev.) + Hepatic artery infusion chemotherapy (HAIC) with FOLFOX regimen
Receives: Procedure: HAI Adebrelimab; Drug: intravenous infusion (IV) of Bevacizumab (Bev.); Procedure: HAIC with FOLFOX regimen; Drug: Adebrelimab and bevacizumab maintainance treatment
HAIBrave-001 Arm 2ExperimentalIntravenous infusion (IV) of Adebrelimab (ADE) + intravenous infusion (IV) of Bevacizumab (Bev.)+ HAIC with FOLFOX regimen
Receives: Drug: intravenous infusion (IV) of Adebrelimab (ADE); Drug: intravenous infusion (IV) of Bevacizumab (Bev.); Procedure: HAIC with FOLFOX regimen; Drug: Adebrelimab and bevacizumab maintainance treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    Defined as the proportion of enrolled patients in each group who achieve either a complete response (CR) or partial response (PR) as the best response during the study, based on RECIST v1.1 criteria. Radiology imaging evaluations will be conducted every 6 weeks (or after every two treatment cycles) to assess treatment efficacy.

    Measured: From first dose until confirmed disease progression, treatment discontinuation, or end of study, whichever occurs first; tumor imaging assessments every 6 weeks (42 ± 7 days), with confirmation of initial response at least 4 weeks later.

Secondary outcomes (7)

  1. Progression-free survival (PFS)

    The time from the start of treatment to the first occurrence of disease progression based on RECIST 1.1 criteria or death.

    Measured: 36 months

  2. Overall survival(OS)

    Overall Survival (OS): Patient survival status will be regularly monitored through on-site visits or telephone follow-ups after the end of study treatment until death. If a participant dies during the study, the actual time of death will be recorded.

    Measured: 36 months

  3. Time to progression

    Time from the date of initial treatment to disease progression based on RECIST 1.1 criteria.

    Measured: 36 months

  4. Disease control rate

    The proportion of patients with best response of complete remission, partial remission or stable disease based on RECIST 1.1 criteria.

    Measured: 36 months

  5. Duration of response

    Refer to the time from the first documentation of complete remission or partial remission to the time of imaging-based disease progression based on RECIST 1.1 criteria.

    Measured: 36 months

  6. Best overall response

    Refer to the best overall response between the date of enrollment to the date of disease progression or the initiation date of other sequential treatments.

    Measured: 36 months

  7. Incidence and Severity of Adverse Events (AEs)

    Evaluate the incidence and severity of adverse events (AEs) according to NCI-CTCAE v5.0 criteria.

    Measured: From the date of informed consent signature up to 30 days after the last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2024
  2. Study start3 Jan 2025
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A total of 76 patients (anticipated) will be randomized (1:1) to two arms to receive Hepatic arterial infusion (HAI) of Adebrelimab (ADE) (1200mg, IA, Q3W) and intravenous infusion (IV) of Bevacizumab (Bev.) (15mg/kg, IV, Q3W) plus HAIC with FOLFOX regimen (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil bolus 400 mg/m2 on day 1, and 5-fluorouracil infusion 2500 mg/m2 for 46 hours via hepatic artery Q4W) or intravenous infusion (IV) of Adebrelimab (ADE) (1200mg, IV, Q3W) and intravenous infusion (IV) of Bevacizumab (Bev.) (15mg/kg, IV, Q3W) plus HAIC with FOLFOX regimen (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil bolus 400 mg/m2 on day 1, and 5-fluorouracil infusion 2500 mg/m2 for 46 hours via hepatic artery, Q3W). The Two arms continue the triple combination treatment up to 6 cycles and then received receive intravenous combination therapy of adebrelimab and bevacizumab for maintainance until disease progression or intolerable toxicity.
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06737913
Sponsor's protocol ID
B2024-588-01
Other IDs
ChiCTR2400092928
Acronym
HAIBrave-001
Status last verified
Sep 2026
First submitted
11 Dec 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because the informed consent does not explicitly permit data sharing with other researchers, and patient privacy and institutional data ownership policies apply. Only summary results will be published.

Publications

  • Shen L, Lin L, Zhang Y, Fang X, Lan H, Fan W. Hepatic arterial infusion or intravenous infusion of adebrelimab, combined with bevacizumab and HAIC of the FOLFOX regimen for advanced unresectable hepatocellular carcinoma (HAIBrave-001 trial): a study protocol of a prospective, double-arm, phase II trial. J Gastrointest Oncol. 2026 Aug 31;17(4):267. doi: 10.21037/jgo-2026-0607. Epub 2026 Jul 9.

    PubMed 42703324

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HAI Adebrelimab, intravenous infusion (IV) of Adebrelimab (ADE) and intravenous infusion (IV) of Bevacizumab (Bev.) in people with Advanced Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University at 3 sites 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 16 inclusion and 14 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Lujun Shen, M.D. (86-13560365452, shenlj@sysucc.org.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: From first dose until confirmed disease progression, treatment discontinuation, or end of study, whichever occurs first; tumor imaging assessments every 6 weeks (42 ± 7 days), with confirmation of initial response at least 4 weeks later.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06737913, which also lists 1 linked publication.

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 25 Sep 2026.

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