Actively Recruiting
Lenvatinib Combined with Tislelizumab and TACE Applied As Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma with High-risk Recurrence Factors
Led by Zhejiang Cancer Hospital · Updated on 2025-02-11
35
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a monocenter, single-arm, open-label study to evaluate the efficacy and safety of Lenvatinib combined with Tislelizumab and TACE applied as neoadjuvant regimen for the patients of CNLC stage IB and IIA hepatocellular carcinoma with high risk of recurrence Primary outcome: Major pathological response (MPR) Secondary outcomes: pathological complete response (pCR), R0 resection rate, objective response rate (ORR), disease control rate (DCR), treatment-related adverse events (TRAE)
CONDITIONS
Official Title
Lenvatinib Combined with Tislelizumab and TACE Applied As Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma with High-risk Recurrence Factors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years old (inclusive)
- Confirmed hepatocellular carcinoma by pathology or diagnostic criteria with no prior anti-tumor treatment for HCC
- CNLC stage IB or IIA tumor with narrow or no surgical margin on imaging and preoperative tumor markers AFP and PIVKA both greater than 1600
- ECOG performance status score of 0 before first study drug administration
- Child-Pugh liver function score of 5-6, grade A
- Expected survival time of at least 16 weeks
- Adequate organ function including hemoglobin ≥90 g/L, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, liver enzymes ≤5 times upper limit, alkaline phosphatase ≤2.5 times upper limit, serum albumin ≥30 g/L, creatinine <1.5 times upper limit, INR ≤2 or PT ≤6 seconds, creatinine clearance rate ≥60 mL/min
- Agree to use effective contraception during the study if of childbearing potential
- Provide informed consent and tumor tissue samples or fresh biopsy specimens
You will not qualify if you...
- Non-hepatocellular carcinoma diagnosis
- Prior anti-tumor treatments for liver cancer, including chemotherapy, radiotherapy, ablation, intervention, targeted therapy, immunotherapy, or surgery (except non-tumor surgery or biopsy)
- CNLC stage IA, IIB or more advanced disease
- High viral load: hepatitis B virus DNA >2000 copies/ml or hepatitis C virus RNA >1000
- Long-term use of systemic steroids (>10 mg prednisone daily) or other immunosuppressive treatments
- Significant bleeding or bleeding tendency within 3 months or current anticoagulation/thrombolysis treatment
- Intestinal obstruction requiring treatment unless relieved by fistula or stent
- Active severe infection or untreated active tuberculosis; known or suspected autoimmune disease
- Uncontrolled diabetes (fasting glucose ≥10 mmol/L), severe lung disease, or interstitial lung disease
- Clinically significant cardiovascular disease or uncontrolled hypertension
- Undergoing renal replacement therapy
- Other malignant tumors within past 5 years, except cured basal cell carcinoma or cervical intraepithelial neoplasia
- Unable to tolerate surgery
- Allergic reactions to any study drug components
- Alcohol dependence, mental illness, pregnancy, lactation, or other unsuitable conditions for clinical trial participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
1# Banshan East Rd. Zhejiang cancer hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
Y
Yuhua Zhang, 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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