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

ConditionAdvanced Hepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • HAI Adebrelimab

    Procedure/Surgery

    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 regimen

    Procedure/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 treatment

    Drug

    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

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: HAIBrave-001 Arm 1Experimental treatment 4 interventions
Group B: HAIBrave-001 Arm 2Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

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.

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.

Secondary outcomes

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.

Time frame
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.

Time frame
36 months
3

Time to progression

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

Time frame
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.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Henan Provincial People's Hospital

Collaborator

First Affiliated Hospital of Fujian Medical University

Collaborator

Shanghai Zhongshan Hospital

Collaborator

Cancer Hospital of Guangxi Medical University

Collaborator

The Seventh Affiliated Hospital of Sun Yat-sen University

Collaborator

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Collaborator

West China Hospital

Collaborator

Hunan Provincial Cancer Hospital

Collaborator

Gansu Provincial Cancer Hospital

Collaborator

Source ClinicalTrials.gov
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