OncoMatch/Clinical Trials/NCT05920863
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
Is NCT05920863 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Tislelizumab, Lenvatinib for hepatocellular carcinoma.
Treatment: Tislelizumab, Lenvatinib — 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage CNLC IB, CNLC IIA (CNLC)
Excluded: Stage CNLC IA, CNLC IIB
Patients with CNLC IB or IIA stage tumors before surgery...Exclusion: CNLC stage is IA, IIB or worse.
Performance status
ECOG 0–0(Fully active)
Demographics
Prior therapy
Cannot have received: systemic chemotherapy
No prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments for HCC
Cannot have received: immunotherapy
No prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments for HCC
Cannot have received: targeted therapy
No prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments for HCC
Cannot have received: other anti-tumor treatments
No prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments for HCC
Cannot have received: chemotherapy
Previously received anti-tumor treatments such as chemotherapy, radiotherapy, radiofrequency ablation, intervention, targeted therapy, immunotherapy or surgical treatment for liver cancer (excluding previous non-tumor-related surgery or diagnostic biopsy)
Cannot have received: radiotherapy
Previously received anti-tumor treatments such as chemotherapy, radiotherapy, radiofrequency ablation, intervention, targeted therapy, immunotherapy or surgical treatment for liver cancer (excluding previous non-tumor-related surgery or diagnostic biopsy)
Cannot have received: radiofrequency ablation
Previously received anti-tumor treatments such as chemotherapy, radiotherapy, radiofrequency ablation, intervention, targeted therapy, immunotherapy or surgical treatment for liver cancer (excluding previous non-tumor-related surgery or diagnostic biopsy)
Cannot have received: intervention
Previously received anti-tumor treatments such as chemotherapy, radiotherapy, radiofrequency ablation, intervention, targeted therapy, immunotherapy or surgical treatment for liver cancer (excluding previous non-tumor-related surgery or diagnostic biopsy)
Cannot have received: targeted therapy
Previously received anti-tumor treatments such as chemotherapy, radiotherapy, radiofrequency ablation, intervention, targeted therapy, immunotherapy or surgical treatment for liver cancer (excluding previous non-tumor-related surgery or diagnostic biopsy)
Cannot have received: immunotherapy
Previously received anti-tumor treatments such as chemotherapy, radiotherapy, radiofrequency ablation, intervention, targeted therapy, immunotherapy or surgical treatment for liver cancer (excluding previous non-tumor-related surgery or diagnostic biopsy)
Cannot have received: surgical treatment for liver cancer
Exception: excluding previous non-tumor-related surgery or diagnostic biopsy
Previously received anti-tumor treatments such as chemotherapy, radiotherapy, radiofrequency ablation, intervention, targeted therapy, immunotherapy or surgical treatment for liver cancer (excluding previous non-tumor-related surgery or diagnostic biopsy)
Lab requirements
Blood counts
hemoglobin ≥90g/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L
Kidney function
serum creatinine <1.5 ULN; creatinine clearance rate ≥60 mL/min
Liver function
Child-Pugh scores is 5-6 points and liver function is grade A; aspartate aminotransferase or alanine aminotransferase ≤5 times the upper limit of normal (ULN), alkaline phosphatase ≤2.5 ULN, serum albumin ≥30g/L
Pre-administration organ function levels meet the requirements and are tolerant of surgery. The functional indicators of important organs meet the following requirements: hemoglobin ≥90g/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L; aspartate aminotransferase or alanine aminotransferase ≤5 times the upper limit of normal (ULN), alkaline phosphatase ≤2.5 ULN, serum albumin ≥30g/L; serum creatinine <1.5 ULN; international normalized ratio (INR) ≤2 or prothrombin time (PT) within the upper limit of normal range ≤6 seconds; serum creatinine ≤1.5 ULN, creatinine clearance rate ≥60 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05920863 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage CNLC IB or CNLC IIA is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages