Actively Recruiting
A Randomized, Double-blind, Multi-center Phase II Study to Evaluate HLX53 Combined with Serplulimab Injection (HLX10) and HLX04 Compared to Placebo with HLX10 and HLX04 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the best dosage and evaluating how well and how safely Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a biosimilar to Bevacizumab) work, with or without HLX53 (an Anti-TIGIT Fc Fusion Protein), in patients who have untreated, locally advanced, or metastatic hepatocellular carcinoma. This study is a Phase II randomized, double-blind, multi-center trial focused on these treatments in patients with this type of liver cancer. Participants receive one of three treatments every three weeks: either HLX53 at 1000 mg or 2000 mg combined with HLX10 and HLX04, or a placebo combined with HLX10 and HLX04. All drugs are given through intravenous infusion on Day 1 of each 21-day cycle. Treatment continues until unacceptable side effects occur or until the treatment no longer benefits the patient as judged by the investigator. During the study, patients are monitored closely for tumor response and progression using measures such as objective response rate (ORR) and progression-free survival (PFS) over up to 14 months, as well as overall survival up to about 36 months. Safety is assessed by tracking any adverse events for up to 24 months. Patients will undergo clinical evaluations, imaging scans, and laboratory tests throughout the study to assess treatment effects and side effects.
CONDITIONS
Brief 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...
- Age 18 years or older
- Volunteers willing to sign informed consent and complete all procedures
- Diagnosis of hepatocellular carcinoma with cirrhosis by AASLD standards or by biopsy if non-cirrhotic
- No prior systemic treatment for hepatocellular carcinoma
- BCLC stage C, or BCLC stage B not suitable for local therapy
- At least one measurable target lesion per RECIST v1.1 within 4 weeks prior to first treatment
- Tumor tissue available for PD-L1 expression evaluation if possible
- Previous local treatments resolved to low-grade adverse events
- Child-Pugh liver function grade A or good grade B (score ≤ 7)
- ECOG performance status 0 or 1
- Expected survival of at least 12 weeks
- Adequate blood and organ function
You will not qualify if you...
- Other liver cancers such as hepatobiliary duct carcinoma or mixed cell carcinoma
- History of hepatic encephalopathy or liver transplant; prior or planned organ/bone marrow transplantation
- Recent portal hypertension with bleeding or high risk of bleeding
- Portal vein invasion of main branch (Vp4) or involvement of inferior vena cava or heart
- Untreated or worsening brain or leptomeningeal metastases
- Second primary cancer within 2 years except certain early-stage treated cancers
- Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage
- HIV infection
- Active tuberculosis
- Lung diseases interfering with lung toxicity assessment
- Active or suspected autoimmune diseases (except controlled hypothyroidism or type 1 diabetes)
- Active infection needing systemic anti-infective treatment within 14 days
- Significant bleeding events recently or during screening
- Severe allergies to monoclonal antibodies or study drug components
- Prior treatment with immune checkpoint therapies or bevacizumab or anti-TIGIT therapies
- Other factors judged by investigator making participation unsuitable
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 - Up to 24 weeks or until unacceptable toxicity or loss of clinical benefit
Participants receive HLX53, HLX10, and HLX04 or placebo with HLX10 and HLX04 by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit.
Infusions every 3 weeks
Duration - Up to approximately 36 months
Participants are monitored for progression, survival, and safety outcomes after treatment ends.
Visits scheduled periodically for up to 36 months
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
Research Team
J
Jia Fan, Dr
H
Huichuan Sun, Dr
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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