Actively Recruiting
Lenvatinib Combined with Tislelizumab and TACE as Preoperative Treatment for CNLC Stage IB and IIA Hepatocellular Carcinoma with High Risk of Recurrence
Led by Zhejiang Cancer Hospital · Updated on 2025-02-11
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Lenvatinib, Tislelizumab, and TACE as a preoperative treatment for patients with stage IB and IIA hepatocellular carcinoma (HCC) who have a high risk of cancer recurrence. This phase 2, single-arm, open-label study focuses on improving outcomes for patients with narrow or no surgical margins and high tumor marker levels. The study aims to assess the major pathological response along with other important measures such as complete response, surgical success, tumor control, and treatment side effects. The treatment includes TACE cycles with pharmorubicin and oxaliplatin every 4 to 5 weeks, Tislelizumab given every 3 weeks at 200mg, and daily Lenvatinib dosed based on body weight (8mg for under 60kg, 12mg for 60kg or above). Patients receive these treatments before surgery as part of the neoadjuvant regimen. The study period for evaluating responses and safety is approximately 16 weeks, including up to four treatment cycles. Participants will undergo evaluations such as pathological assessments of tumor response, imaging to measure tumor control, and monitoring for any treatment-related adverse events during the treatment period. Liver function and organ health will be closely followed, along with survival outcomes related to recurrence-free survival. The total participation time covers the treatment cycles and follow-up assessments up to 16 weeks after starting the regimen.
CONDITIONS
Brief 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 18-75 years old (inclusive)
- Confirmed hepatocellular carcinoma by pathology or diagnostic criteria with no prior systemic or anti-tumor treatments
- CNLC stage IB or IIA tumors with narrow or no surgical margins and AFP+PIVKA tumor markers >1600
- ECOG performance status score of 0 before treatment
- Child-Pugh liver function grade A with scores 5-6
- Expected survival time of at least 16 weeks
- Adequate organ function with specific blood counts and liver/kidney function tests
- Agreement to use effective contraception if of childbearing potential
- Signed informed consent and agreement to provide tumor tissue samples
You will not qualify if you...
- Diagnosis of non-hepatocellular carcinoma
- Prior anti-tumor treatments for liver cancer including chemotherapy, radiotherapy, ablation, targeted, immunotherapy, or surgery (except biopsy or non-tumor surgery)
- CNLC stage IA, IIB, or worse
- High viral loads of hepatitis B or C viruses
- Long-term use of systemic steroids or immunosuppressive therapy
- Significant bleeding or bleeding disorders within 3 months prior or ongoing anticoagulation
- Intestinal obstruction requiring treatment unless relieved by fistula or stent
- Active severe infections including tuberculosis or autoimmune diseases
- Uncontrolled diabetes or severe lung diseases
- Clinically significant cardiovascular disease or uncontrolled hypertension
- Undergoing renal replacement therapy
- History of other cancers within past 5 years (except certain cured types)
- Unable to tolerate surgery
- Allergic reactions to study drug components
- Alcohol dependence, mental illness, pregnancy, or other unsuitable conditions for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive a combination of TACE procedure, Tislelizumab infusions every 3 weeks, and daily oral Lenvatinib as a preoperative neoadjuvant therapy.
Up to 4 cycles of treatment with visits every 3 to 4 weeks
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
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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