Actively Recruiting
A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy
Led by Shanghai Henlius Biotech · Updated on 2025-03-10
90
Participants Needed
1
Research Sites
117 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 HLX43 (Anti-PD-L1 ADC) in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed or Intolerance to Standard Therapy
CONDITIONS
Official Title
A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Confirmed hepatocellular carcinoma by biopsy, cytology, or clinical criteria
- Previous failure, progression, or intolerance to at least one standard systemic therapy for HCC
- Barcelona Clinic Liver Cancer (BCLC) stage C or B patients not suitable for locoregional therapy
- At least one measurable tumor lesion per RECIST v1.1 within 4 weeks before treatment
- Tumor tissue available for PD-L1 expression evaluation
- Adequate recovery from prior therapies and required intervals since last treatments
- Child-Pugh liver function class A within 7 days before study drug
- ECOG performance status 0-1 in the week before randomization
- Expected survival of at least 3 months
- Controlled hepatitis B or C infection status per specified viral load and treatment requirements
- Adequate organ function confirmed by labs within 14 days prior to treatment
- Agreement to use effective contraception during and 6 months after study; negative pregnancy test for females of childbearing potential
You will not qualify if you...
- Other liver cancer types like hepatobiliary duct cell, mixed cell, or fibroblastic carcinoma
- Second malignancy within past 2 years except certain early-stage cancers
- History of hepatic encephalopathy or liver transplant; prior organ or bone marrow transplant
- Recent or high-risk gastrointestinal bleeding or portal hypertension complications
- Portal vein invasion or cancer thrombus with major blood flow obstruction
- Uncontrolled pleural, pericardial effusion, or ascites despite intervention
- Untreated or worsening brain or central nervous system metastases
- Major surgery or local liver treatments within 4 weeks prior to randomization
- Recent radiation therapy within specified time frames
- Previous or current lung diseases that may interfere with lung toxicity assessment
- Severe allergies to monoclonal antibodies or drug components
- Active systemic infection requiring intravenous antibiotics within 2 weeks
- Poorly controlled cardiovascular conditions or recent serious cardiac events
- History of grade 3 or higher immune-related adverse effects from past immunotherapy
- Active or suspected autoimmune disease, with exceptions for controlled hypothyroidism and type 1 diabetes
- Recent systemic corticosteroid or immunosuppressive treatment within 14 days, with exceptions
- Live vaccinations within 4 weeks before dosing, except inactivated influenza vaccine
- Use of strong CYP2D6 or CYP3A inhibitors or inducers within 2 weeks
- Active tuberculosis or HIV infection
- Pregnant or breastfeeding women
- Other factors deemed unsuitable by the researcher for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Hunan, Hunan, China, 410013
Actively Recruiting
Research Team
H
Hua Xiang, Dr.
CONTACT
S
Shanzhi Gu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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