Actively Recruiting
A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
Led by Shanghai Henlius Biotech · Updated on 2024-12-18
117
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
CONDITIONS
Official Title
A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer and able to understand and sign informed consent
- Age 18 years or older
- Diagnosis of cirrhosis by AASLD standards or hepatocellular carcinoma confirmed by histology
- No prior systemic treatment for hepatocellular carcinoma
- Barcelona Clinic Liver Cancer stage C or stage B unsuitable for locoregional therapy
- At least one measurable target lesion per RECIST v1.1 within 4 weeks before treatment
- Tumor tissue available for PD-L1 expression evaluation if possible
- Previous local treatments resolved to grade 1 or less adverse events
- Child-Pugh liver function grade A or good grade B (7 points or less) within 7 days before treatment
- ECOG performance status 0 or 1 within 7 days before treatment
- Expected survival of 12 weeks or more
- Adequate blood and organ function
You will not qualify if you...
- Hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma
- History of hepatic encephalopathy or liver transplant
- Organ or bone marrow transplant history or preparation
- Recent portal hypertension with bleeding or high risk of bleeding
- Portal vein invasion Vp4 with inferior vena cava or heart involvement
- Untreated or worsening brain or leptomeningeal metastases
- Second primary malignancy within 2 years except early-stage treated cancers
- Recurrent uncontrolled fluid buildup needing frequent drainage
- HIV infection
- Active tuberculosis
- Previous or current serious lung diseases affecting lung function
- Active or suspected autoimmune disease except controlled hypothyroidism or type 1 diabetes
- Active infection requiring systemic anti-infective treatment within 14 days before treatment
- Recent or current significant bleeding events
- Severe allergies to monoclonal antibodies or study medication components
- Previous treatment with immune checkpoint inhibitors, bevacizumab, or anti-TIGIT therapies
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
Research Team
J
Jia Fan, Dr
CONTACT
H
Huichuan Sun, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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