Actively Recruiting
TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for Hepatocellular Carcinoma With Branch Portal Vein Tumor Thrombosis: A Randomized Clinical Trial
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-02-11
234
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Third Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor
S
Sun Yat-Sen University Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a combination treatment involving Atezolizumab/Bevacizumab, transcatheter arterial chemoembolization (TACE), and I-125 Seeds Brachytherapy (TACE-AB-I) in patients with advanced hepatocellular carcinoma (HCC) who also have portal vein tumor thrombosis (PVTT). This multicenter, randomized controlled trial aims to compare this combination therapy with the administration of Atezolizumab/Bevacizumab plus TACE (TACE-AB). The study focuses on patients with advanced HCC and Type I or II PVTT as classified by Cheng's PVTT classification. Participants will be randomly assigned to receive either TACE-AB-I or TACE-AB in equal proportions. All patients will undergo TACE after randomization. For those in the TACE-AB-I group, iodine-125 seeds will be implanted into the PVTT under CT guidance within 3 to 7 days after the first TACE. Atezolizumab (1,200 mg) and Bevacizumab (15 mg/kg) will be administered intravenously every 3 weeks, beginning 3 to 7 days after the first TACE and I-125 seed implantation in the experimental group, or after the first TACE in the comparator group. Both TACE and seed implantation can be repeated during follow-up as needed based on laboratory and imaging evaluations. During the study, participants will be monitored through laboratory tests and imaging to assess treatment response and safety. Researchers will evaluate overall survival over two years as the primary outcome. Secondary outcomes include progression-free survival, objective response rate, duration of portal vein openness, and adverse events, all tracked for two years. The study will continue until disease progression, unacceptable toxicity, withdrawal, loss of follow-up, death, or other reasons requiring treatment termination. The total participation duration may extend up to two years with ongoing assessments to ensure safety and treatment effectiveness.
CONDITIONS
Brief Title
TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
- Type I or type II portal vein tumor thrombosis
- Child-Pugh class A liver function
- Eastern Cooperative Group performance status score of 0-1
- No prior systemic therapy for hepatocellular carcinoma
- Adequate blood and organ function
- At least one measurable tumor lesion inside the liver
You will not qualify if you...
- Diffuse hepatocellular carcinoma
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, or mixed hepatocellular/cholangiocarcinoma
- Evidence of cancer spread outside the liver
- Contraindications to TACE or I-125 seeds brachytherapy
- Recent history of serious bleeding or bleeding disorders
- Active or past autoimmune disease or immune deficiency
- Untreated or high-risk esophageal or gastric varices
- Pregnant or breastfeeding women
- Significant heart disease
- Severe infections such as active tuberculosis
- Serious other medical conditions
- History of organ or cell transplantation
- Other incurable cancers
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression, intolerable toxicity, withdrawal, loss of follow-up, death, or other termination criteria
Participants receive transcatheter arterial chemoembolization (TACE). For those in the experimental group, iodine-125 seeds are implanted into the portal vein tumor thrombosis (PVTT) under CT guidance within 3 to 7 days after the first TACE. Atezolizumab and bevacizumab infusions start 3 to 7 days after the first TACE (and I-125 seed implantation if applicable) and continue every 3 weeks until disease progression, intolerable toxicity, withdrawal, loss to follow-up, or other reasons for treatment termination. TACE and I-125 seed implantation may be repeated on demand during follow-up based on evaluations.
Infusions every 3 weeks; additional TACE and I-125 seed implantation visits as needed
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangzhou, China, 510630
Actively Recruiting
Research Team
M
Mingsheng Huang, M.D. & Ph.D.
L
Luwen Mu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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