Actively Recruiting
Lenvatinib Plus Sintilimab in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Liver Cancer
Led by Fudan University · Updated on 2025-02-27
25
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to evaluate the efficacy and safety of Lenvatinib plus Sintilimab in patients with advanced liver cancer progressed after treatment with immune checkpoint inhibitors.
CONDITIONS
Official Title
Lenvatinib Plus Sintilimab in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained.
- Age 18 years or older at study entry.
- Have unresectable or metastatic hepatocellular carcinoma or intrahepatic cholangiocarcinoma confirmed by pathology.
- Disease progression following treatment with an anti-PD-1 or anti-PD-L1 regimen.
- At least one measurable tumor site by RECIST 1.1 criteria on CT or MRI.
- Performance status of 2 or less on the ECOG scale.
- Life expectancy of at least 12 weeks.
- Adequate blood counts, liver enzymes, and kidney function as defined by specific laboratory thresholds.
- Female patients with reproductive potential must have a negative pregnancy test within 7 days before starting.
- Willing and able to follow the study protocol, including treatment, contraceptive measures, visits, and follow-up.
You will not qualify if you...
- History of cardiac disease or significant gastrointestinal bleeding within 4 weeks before starting treatment.
- Thrombotic or embolic events within 6 months before first study drug dose, except segmental portal vein thrombosis.
- Prior treatment with Lenvatinib or other targeted therapies.
- Radiofrequency ablation or surgery less than 4 weeks before study start.
- Radiotherapy less than 4 weeks before study start.
- Major surgery within 4 weeks before study or not recovered from it.
- Second primary cancer except treated basal skin cancer or cervical carcinoma in-situ.
- Immunocompromised status, including HIV infection.
- Participation in another clinical trial with investigational drugs within 30 days or 7 half-lives of prior medication.
- Conditions interfering with treatment evaluation or safety, including interstitial lung disease, pancreatitis, active infections, organ transplant history, immunodeficiency, or recent immunosuppressive therapy.
- Active autoimmune disease requiring recent systemic treatment or severe autoimmune history, except specific stable conditions.
- Live vaccination within 30 days before or during treatment.
- CNS metastases unless treated and stable without steroids for 6 weeks.
- Medications interfering with study drugs.
- Use of other cancer treatments at study start except those in this protocol.
- Received investigational products within 28 days before study start.
- Pregnant or breastfeeding women, or patients not using effective contraception.
- History of non-compliance or inability to give informed consent.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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