This study evaluates a novel "Dual-Conversion" strategy (mechanical volume conversion via LVD plus biological conversion via cTACE, Tislelizumab, and Lenvatinib) for patients with initially unresectable right-sided hepatocellular carcinoma (HCC). The primary goal is to assess the rate of successful conversion to R0 resection and the safety profile of this multi-modal approach.
For patients with large right-sided HCC, resection is often precluded by insufficient future liver remnant (FLR) or high biological aggressiveness. This trial utilizes: 1. Mechanical Conversion: LVD (simultaneous portal and hepatic vein embolization) to trigger rapid FLR hypertrophy. 2. Biological Conversion: cTACE combined with systemic therapy (Tislelizumab + Lenvatinib) to control tumor growth and reduce tumor stage. Patients will undergo "Dual-Conversion" therapy and be assessed for surgical resectability every 3-6 weeks. Success is defined as achieving R0 resection with a safe FLR-to-body weight ratio.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Simultaneous embolization of the right portal vein and right hepatic vein to induce FLR hypertrophy.
Conventional TACE performed using Lipiodol and chemotherapy agents (Epirubicin/Oxaliplatin)
Tislelizumab 200 mg administered intravenously every 3 weeks (Q3W) + 8 mg (for weight \<60 kg) or 12 mg (for weight ≥60 kg) orally once daily (QD)
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Conversion-to-Surgery Rate
The proportion of patients who successfully undergo R0 resection after receiving the dual-conversion therapy
Time frame: From enrollment to the end of treatment at 12 weeks
Objective Response Rate (ORR)
Proportion of patients achieving Complete Response (CR) or Partial Response (PR) based on mRECIST and RECIST 1.1 criteria.
Time frame: Every 4-8 weeks (up to 3 years)
Kinetic Growth Rate (KGR) of FLR
Volume increase of the Future Liver Remnant (FLR) per week (mL/week) measured by CT-based 3D reconstruction post-LVD.
Time frame: 3-4 weeks post-LVD.
Progression-Free Survival (PFS)
Time from enrollment to disease progression or death from any cause.
Time frame: Every 4-8 weeks (up to 3 years).
Incidence of Treatment-Related Adverse Events (TRAEs)
Frequency and severity of adverse events graded by CTCAE v5.0, including TACE/LVD-related complications and immune/target-related toxicities.
Time frame: From the first dose until 30 days after the last treatment (up to 2 years).
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