Actively Recruiting
Cryoablation Combined with Sintilimab Plus Lenvatinib in Previously Treated Unresectable Liver Metastasis from Solid Tumors
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 cryoablation combined with Sintilimab plus lenvatinib for patients with unresectable liver metastasis, who had progressed after, or were refractory to first- or later-line therapy.
CONDITIONS
Official Title
Cryoablation Combined with Sintilimab Plus Lenvatinib in Previously Treated Unresectable Liver Metastasis from Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent.
- Age 18 years or older at study entry.
- Have unresectable liver metastasis from solid tumors.
- Disease progressed after or was resistant to first- or later-line therapy for liver metastasis.
- Previous antiangiogenic or anti-EGFR therapy allowed.
- At least one measurable tumor site by RECIST criteria using 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 within specified limits.
- Negative pregnancy test within 7 days before starting trial for women of reproductive potential.
- Willing and able to follow study protocol, including treatment, contraception, visits, and exams.
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 study drug dose, except segmental portal vein thrombosis.
- Prior cryoablation treatment.
- Radiofrequency ablation or tumor resection less than 4 weeks before study treatment.
- Radiotherapy less than 4 weeks before study treatment.
- Major surgery within 4 weeks before study treatment or incomplete recovery from surgery.
- Second primary cancer except treated basal skin cancer or cervical carcinoma in situ.
- Immunocompromised status, including HIV positive.
- Participation in another trial with investigational products within 30 days or 7 half-lives of prior medication.
- Conditions interfering with study evaluation or safety, such as interstitial lung disease, HBV/HCV coinfection, pancreatitis, active infections, organ transplant history, immunodeficiency, recent immunosuppressive therapy, active severe autoimmune disease, or recent live vaccination.
- CNS metastases unless asymptomatic, off steroids for 6 weeks, and completed local therapy.
- Medications interfering with study agents.
- Use of other cancer treatments besides study protocol at treatment start.
- Use of other investigational products within 28 days before study.
- Pregnancy, breastfeeding, or ineffective birth control in patients of reproductive potential.
- History of non-compliance or inability to provide 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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