Actively Recruiting
Cryoablation Combined with Tislelizumab Plus Lenvatinib As Second-line or Later Therapy in Advanced Hepatocellular Carcinoma
Led by Fudan University · Updated on 2025-02-27
25
Participants Needed
1
Research Sites
260 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 cryoablation combined with Tislelizumab plus lenvatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma.
CONDITIONS
Official Title
Cryoablation Combined with Tislelizumab Plus Lenvatinib As Second-line or Later Therapy in Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained
- Age 18 years or older at study entry
- Histologically or cytologically confirmed unresectable or metastatic hepatocellular carcinoma
- Failed one line of systemic treatment for advanced hepatocellular carcinoma due to progression or toxicity
- Refractory or intolerant to previous chemotherapy, targeted therapy, or anti-PD-1/PD-L1 regimen
- At least one measurable tumor site by RECIST criteria on CT or MRI
- Performance status 2 or less on ECOG scale
- Life expectancy of at least 12 weeks
- Adequate blood counts, liver enzymes, and kidney function as specified
- Negative pregnancy test within 7 days prior to trial start for females with reproductive potential
- Willing and able to comply with protocol and scheduled visits
You will not qualify if you...
- History of cardiac disease or significant gastrointestinal bleeding within 4 weeks before treatment
- Thrombotic or embolic events within 6 months before first dose, except segmental portal vein thrombosis
- Prior treatment with cryoablation
- Radiofrequency ablation or resection within 4 weeks before treatment start
- Radiotherapy within 4 weeks before treatment start
- Major surgery within 4 weeks before treatment or not recovered from surgery effects
- Second primary cancer except treated basal skin cancer or cervical carcinoma in situ
- Immunocompromised status including HIV positive
- Participation in another clinical trial with investigational product within 30 days or 7 half-lives of prior medication
- Conditions interfering with treatment evaluation or safety including interstitial lung disease, HBV/HCV coinfection, pancreatitis, active infections, organ transplant, immunodeficiency, recent steroid or immunosuppressive therapy
- Active autoimmune disease requiring systemic treatment within past 3 months or severe autoimmune history
- Live vaccine within 30 days before or during treatment
- CNS metastases unless asymptomatic and off steroids for 6 weeks
- Medications interfering with study agents
- Any other effective cancer treatment at study start
- Investigational product use within 28 days before study entry
- Pregnancy, breastfeeding, or inadequate contraception for patients of reproductive potential
- History of non-compliance or inability to give reliable 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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