Actively Recruiting
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Intermediate and Advanced Hepatocellular Carcinoma: a Prospective Phase II Study
Led by Sun Yat-sen University · Updated on 2024-12-03
27
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of combining drug-eluting transcatheter arterial embolization and hepatic arterial infusion chemotherapy (dTACE-HAIC) with the drugs Bevacizumab and Atezolizumab for patients who have intermediate to advanced large hepatocellular carcinoma (HCC). The study focuses on patients with large tumors who cannot undergo radical therapy, exploring a treatment approach that combines locoregional therapy with targeted and immune-based medications. The treatment involves a procedure where a microcatheter is carefully inserted into the artery feeding the tumor, followed by the delivery of drug-eluting microspheres. Patients then receive hepatic arterial infusion chemotherapy with oxaliplatin, fluorouracil, and leucovorin every four weeks. Additionally, oral Lenvatinib is given daily, and Toripalimab is administered intravenously every two weeks. This study tests the combination of these procedures and medications to assess their impact on large hepatocellular carcinoma. Participants will undergo evaluations including imaging and lab tests to monitor tumor response and safety throughout the study. Researchers will measure the objective response rate after 12 months as the primary outcome, with progression-free survival at 12 months and overall survival at 24 months as secondary outcomes. The study is expected to last until June 2026, with ongoing safety and efficacy monitoring during this period.
CONDITIONS
Brief Title
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of hepatocellular carcinoma (HCC)
- Age between 18 and 75 years
- Largest tumor size 10 cm or greater
- Intermediate to advanced large HCC, including advanced HCC with portal vein tumor thrombosis (PVTT) types I-III
- Limited metastases (5 or fewer)
- Child-Pugh liver function class A or B
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Hemoglobin level at least 8.5 g/dL
- Total bilirubin 30 mmol/L or less
- Serum albumin 32 g/L or higher
- AST and ALT levels no more than 5 times the upper limit of normal
- Serum creatinine no more than 1.5 times the upper limit of normal
- International normalized ratio (INR) 1.5 or less or normal prothrombin time
- Absolute neutrophil count greater than 1,500/mm3
- Prothrombin time 18 seconds or less or INR less than 1.7
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- Diffuse hepatocellular carcinoma
- More than 5 metastases outside the liver
- Obstructive portal vein tumor thrombosis involving the mesenteric vena cava (PVTT type IV)
- Serious other medical conditions
- Signs of liver failure such as ascites, gastrointestinal bleeding, or hepatic encephalopathy
- Untreated or high-risk esophageal or gastric varices with bleeding risk
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or higher
- Known or suspected allergy to study drugs or related agents
- Cardiac arrhythmias needing anti-arrhythmic treatment
- Evidence of bleeding disorders
- Significant gastrointestinal bleeding within 30 days before study start
AI-Screening
AI-Powered Screening
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 - Ongoing treatment cycles every 4 weeks
Participants receive drug-eluting transcatheter arterial embolization (dTACE) combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil, and leucovorin every 4 weeks, along with Bevacizumab and Atezolizumab infusions.
Visits every 2 to 4 weeks for treatment administration
Trial Site Locations
Total: 1 location
1
Chinese PLA General hospital
Beijing, None Selected, China, 100853
Actively Recruiting
Research Team
Q
Qunfang Zhou, MD
Y
Ye Liang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here