Actively Recruiting
Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab
Led by Fudan University · Updated on 2025-07-03
146
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of lenvatinib plus tislelizumab versus lenvatinib alone for patients with advanced hepatocellular carcinoma (HCC) who have progressed on prior systemic treatment with Anti-PD1/PD-L1 plus bevacizumab combination.
CONDITIONS
Official Title
Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained.
- Age 18 years or older at study entry.
- Diagnosis of locally advanced, metastatic, or unresectable hepatocellular carcinoma confirmed by histology, cytology, or clinical criteria.
- Disease progression after prior Anti-PD1/PD-L1 plus bevacizumab treatment.
- At least one measurable target lesion per RECIST v1.1 not previously treated or showing progression after local therapy.
- Child-Pugh score between 5 and 7 and ECOG performance status of 2 or less.
- For chronic HBV infection, viral load less than 100 IU/mL at screening and on antiviral therapy as per guidelines.
- Life expectancy of at least 12 weeks.
- Adequate blood counts, liver enzymes, and kidney function within specified limits.
- Negative pregnancy test within 7 days prior to trial start for females with reproductive potential.
- Willing and able to follow the study protocol including treatment, contraceptive measures, visits, and examinations.
You will not qualify if you...
- Known fibrolamellar, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma.
- Listed for liver transplantation or having advanced liver disease.
- History of cardiac disease or significant gastrointestinal bleeding within 4 weeks before study treatment.
- Thrombotic or embolic events within 6 months before first dose, except segmental portal vein thrombosis.
- Presence of a second primary cancer except treated basal skin cancer or carcinoma in-situ of the cervix.
- Immunocompromised status, including HIV infection.
- Participation in another investigational study within 30 days or 7 half-lives of prior medication.
- Conditions interfering with study evaluation or safety including interstitial lung disease, HBV/HCV coinfection, pancreatitis, active infections, organ transplant, immunodeficiency, recent systemic steroid or immunosuppressive therapy, active autoimmune disease requiring systemic treatment, recent live vaccinations, or CNS metastases except controlled cases.
- Use of medications that interfere with study drugs.
- Any other effective cancer treatment besides protocol treatment at study start.
- Receipt of other investigational products within 28 days of study entry.
- Pregnant, breastfeeding, or not using effective contraception if of reproductive potential.
- History of significant non-compliance or inability to provide informed consent.
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, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
P
Peng Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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