Actively Recruiting
Phase 2 Study of WGI-0301 for Advanced HCC
Led by Zhejiang Haichang Biotech Co., Ltd. · Updated on 2026-03-19
60
Participants Needed
4
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors.
CONDITIONS
Official Title
Phase 2 Study of WGI-0301 for Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent, any gender
- Able and willing to provide signed informed consent and comply with study procedures
- Confirmed diagnosis of hepatocellular carcinoma (HCC) by histology, cytology, or clinical criteria
- BCLC Stage C or B with bilobar, infiltrative disease suitable only for systemic therapy
- Stage 1 only: prior failure, unsuitability, or intolerance to first-line standard treatments
- Stage 2 only: prior failure or intolerance to first-line standard treatments
- Stage 3 only: documented progression or intolerance after one prior systemic immunotherapy line including anti-PD-1/PD-L1 antibodies
- Eligible for Sorafenib treatment as per investigator judgment
- ECOG performance status of 0 or 1 within 7 days before first dose
- At least one measurable tumor lesion not recently treated locally, or with measurable new progression
- Life expectancy greater than 12 weeks
- Recovery to Grade 1 or less from prior treatment toxicities unless clinically insignificant or stable
- Stage 2 and 3: agree to provide archived tissue or undergo biopsy for biomarker testing
- Adequate organ function including Child-Pugh Class A or B (score ≤7), liver enzymes ≤3x upper limit, bilirubin ≤2x upper limit, albumin ≥2.8 g/dL, creatinine clearance ≥40 mL/min, INR ≤2.0 (except warfarin therapy), and specified blood counts
- Patients with HBV or HCV infection allowed if controlled and managed per criteria
- Women of childbearing potential must have negative pregnancy test before first dose and use effective contraception during and 6 months after treatment; men must agree to contraception during and 3 months after treatment
You will not qualify if you...
- Pregnant or breastfeeding, or planning to conceive or father children during the study
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma (Stages 2 and 3)
- Complete blockage of major portal vein or vena cava by tumor
- Major surgery within 4 weeks before first dose
- Known allergy or hypersensitivity to WGI-0301, liposomal drugs, Sorafenib, or similar agents
- Prior Sorafenib or AKT-PI3K pathway-targeting therapy (Stage 3 only)
- Participation in another investigational study with treatment within 4 weeks prior to first dose
- Recent liver-directed therapies or radiotherapy within specified timeframes
- Recent use of other antitumor treatments or traditional Chinese medicine with antitumor effects
- Use of strong CYP3A4 inducers within 12 days before first dose (Stages 2 and 3)
- Significant glucose metabolism disorders including treated diabetes or HbA1c ≥8.0%
- Significant cardiovascular diseases including uncontrolled hypertension, low blood pressure, severe heart failure or arrhythmias, and low ejection fraction
- Significant gastrointestinal disorders affecting treatment compliance or absorption
- Clinically significant bleeding risks or recent bleeding events
- History of solid organ transplant
- Active HIV/AIDS or recent immunosuppressive therapy
- Active or uncontrolled infections requiring IV treatment
- Uncontrolled fluid buildup requiring repeated drainage
- Other cancers within 3 years except certain treated skin or cervical cancers
- Known brain metastases symptomatic or untreated
- Current drug abuse or addiction
- Any other condition judged by the investigator to interfere with participation or increase risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
China Pharmaceutical University, Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, China, 200131
Actively Recruiting
2
West China Hospital Sichuan University
Chengdu, China
Actively Recruiting
3
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
4
Prince of Wales Hospital
Hong Kong, Hong Kong
Not Yet Recruiting
Research Team
A
Angela Men, MD., Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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