Actively Recruiting
Ablation in Combination With Lenvatinib and Anti-PD-1 Antibodies
Led by Hua Li · Updated on 2024-07-24
70
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lenvatinib is an oral multi-target receptor tyrosine kinase inhibitor (TKI) inhibitor that mainly inhibits the Endothelial growth factor receptor (VEGFR) VEGFR-1,2,3; Fibroblast growth factor receptor, FGFR) FGFR-1,2,3,4; Platelet-derived growth factor receptor (PDGFR) PDGFRα; The kinases RET and KIT, thereby inhibiting tumor cell proliferation, inducing apoptosis, and playing an anti-angiogenic role, have been approved by the FDA and CFDA as first-line treatment for patients with advanced liver cancer. lenvatinib showed longer disease progression than sorafenib (8.9 months vs. sorafenib. 3.7 months), longer progression-free survival (7.4 months vs. 3.7 months), and higher disease control rates (24.1% vs. 9.2%). Therefore, lenvatinib has obvious advantages in HCC treatment because of its strong anti-angiogenic and anti-tumor growth effects. Cindilimab is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking the programmed death receptor-1 (PD-1)/programmed death receptor-1 ligand (PD-L1) pathway induced by tumor immune tolerance, and reactivating the antitumor activity of lymphocytes. In summary, recurrence after radical treatment of liver cancer is an urgent clinical problem. Recurrent HCC treatment represented by resection, ablation and TACE is difficult to achieve more satisfactory efficacy. The main ablative techniques includes radiofrequency ablation, microwave ablation and cryoablation.As a local treatment for liver cancer, ablation has the risk of incomplete ablation and insufficient ablation margin, and because RFA cannot resolve micrometastases, tumor growth, invasion and metastasis occur. Therefore, ablation combined with lenvatinib and immune checkpoint inhibitors have theoretical complementary advantages, and this study intends to compare the clinical efficacy and safety of ablation combined with lenvatinib plus anti-PD-1 antibodies in the treatment of patients with early recurrent liver cancer compared with ablation alone.
CONDITIONS
Official Title
Ablation in Combination With Lenvatinib and Anti-PD-1 Antibodies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- Primary hepatocellular carcinoma confirmed by pathology or clinical diagnosis
- No tumor lesions on imaging 2 months after radical resection or ablation
- Recurrence of HCC within 3 years after surgery without extrahepatic metastasis
- ECOG performance status score of 0 or 1
- Recurrent liver cancer meeting Milan criteria: single tumor 64 5 cm or up to 3 tumors each 64 3 cm, no major vascular invasion, no lymph node or extrahepatic metastasis
- Child-Pugh liver function grade A or B
- Expected survival longer than 6 months
- Adequate organ function and laboratory values within specified limits
- Controlled blood pressure and blood glucose levels if hypertensive or diabetic
- No serious diseases conflicting with the study plan
- No history of other malignant tumors
- Negative pregnancy test for women of childbearing age and use of contraception during and 6 months after the study
- Signed informed consent to participate
You will not qualify if you...
- Prior radiotherapy, hormone therapy, or molecular targeted therapy
- Presence of distant metastasis confirmed by imaging
- History or presence of other malignancies except certain cured skin or cervical cancers
- Allergy to macromolecular protein preparations or anti-PD-1 antibody components
- Active autoimmune diseases or history of autoimmune conditions requiring treatment
- Use of immunosuppressants or systemic/absorbed topical hormones exceeding 10mg/day prednisone equivalent within 2 weeks prior to enrollment
- Uncontrolled or severe heart diseases including heart failure grade 2 or above, unstable angina, recent myocardial infarction, or significant arrhythmias
- Abnormal coagulation or bleeding disorders, or recent thromboembolic events
- Recent or active gastrointestinal bleeding or conditions increasing bleeding risk
- Severe pulmonary diseases including fibrosis, pneumonitis, or impaired lung function
- Immunodeficiency conditions including HIV or active hepatitis beyond controlled levels
- Participation in other clinical trials within 1 month or receiving other systemic anti-tumor therapies during the study
- History of substance abuse
- Tumor recurrence or metastasis detected within 2 months after surgery
- Other serious medical or psychiatric conditions as judged by the investigator that may affect safety or study conduct
- Serious laboratory abnormalities or social factors affecting data collection or safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
H
Hua Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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