Low-Dose Bevacizumab and Atezolizumab Combined With TACE-HAIC in Unresectable Hepatocellular Carc… (NCT07543510) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Low-Dose Bevacizumab and Atezolizumab Combined With TACE-HAIC in Unresectable Hepatocellular Carcinoma
38 participantsStarted 2026-05-01
Plain-language 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 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.
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:
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.
Exclusion Criteria:
Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma; or other ac…
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: 2 years
2
Progression-Free Survival (PFS)
Timeframe: 2 years
Trial details
NCT IDNCT07543510
SponsorThird Affiliated Hospital, Sun Yat-Sen University