Efficacy and Safety of Low-dose Bevacizumab Plus Adebrelimab Combined With Transarterial Chemoemb… (NCT07543783) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of Low-dose Bevacizumab Plus Adebrelimab Combined With Transarterial Chemoembolization Followed by Hepatic Arterial Infusion Chemotherapy (TACE-HAIC) as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Phase 2 Trial
38 participantsStarted 2026-04-10
Plain-language summary
his is a single-arm, phase II clinical study evaluating the efficacy and safety of low-dose bevacizumab (7.5 mg/kg, Q3W) plus adebrelimab (1200 mg, Q3W) combined with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) with the FOLFOX regimen as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). Eligible participants will receive TACE followed by HAIC (oxaliplatin, leucovorin, and fluorouracil) and subsequent intravenous administration of adebrelimab and low-dose bevacizumab every 3 weeks. The primary endpoint is objective response rate (ORR) assessed by investigators per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. A total of 38 participants will be enrolled using Simon's two-stage optimal design (alpha=0.05, power=0.8). The study is sponsored by the Third Affiliated Hospital of Sun Yat-sen University. Adebrelimab is provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Willing to participate and provide written informed consent. Age ≥ 18 years (on the day of signing informed consent). Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or clinical diagnosis of HCC according to AASLD criteria in patients with cirrhosis.
Eligible for TACE, including BCLC stage B or C, with unresectable HCC (excluding PVTT-Vp4 and extrahepatic metastasis).
No prior systemic therapy for HCC. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Child-Pugh score A or B7. No history of autoimmune disease. Life expectancy ≥ 3 months. At least one measurable lesion per RECIST v1.1 (spiral CT scan long diameter ≥ 10 mm or short diameter of enlarged lymph node ≥ 15 mm; lesions previously treated with locoregional therapy can be considered target lesions only if progression per RECIST v1.1 is clearly documented).
Adequate hematologic, hepatic, and renal function within 7 days prior to enrollment:
Neutrophils ≥ 1.5 × 10⁹/L Platelets ≥ 50 × 10⁹/L Hemoglobin ≥ 90 g/L ALT/AST ≤ 5 × ULN Serum creatinine ≤ 1.5 × ULN INR \< 2.3 or prothrombin time ≤ ULN + 6 seconds Albumin ≥ 30 g/L Total bilirubin ≤ 3 × ULN Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be lactating; they and male participants must agree to use effective contraception during the study and for 6 months after study completion
Exclusion Criteria:
Known cholangiocarcin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Up to 36 months from the first dose of study treatment
2
Progression-Free Survival (PFS)
Timeframe: From the first dose of study treatment until disease progression or death, up to 36 months
Trial details
NCT IDNCT07543783
SponsorThird Affiliated Hospital, Sun Yat-Sen University