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

Hepatocellular Carcinoma Clinical Trial

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 of Recurrence: Study Protocol of a Monocenter, Single-arm, Open Label Clincal Trail

Status Recruiting

Clinical Trial Summary

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)

Clinical Trial Description

Surgical treatment is dominant in the treatment of liver cancer, however, its postoperative recurrence rate is high, and the recurrence and metastasis rate in 5 years is as high as 70%. In particular, surgical resection for some large hepatocellular carcinoma adjacent to large vessels or located in middle areas always induces narrow and even no surgical margin, which may increase the risk of postoperative recurrence and decrease the overall survival rate. Preoperative neoadjuvant therapy for resectable hepatocellular carcinoma with high risk of recurrence is still controversial nationally and internationally, none consensus have been reached about neoadjuvant therapy.

As a classical treatment for liver cancer, TACE can induce tumor ischemia and necrosis through the infusion of chemotherapy drugs and embolic materials into target areas. However, TACE as neoadjuvant therapy alone has no improvement in tumor recurrence-free survival time and overall survival rate. Lenvatinib is a multi-target tyrosine kinase inhibitor and inhibits neovascularization and lymphangiogenesis by targeting VEGF1-3 and FGFR. moreover, lenvatinib also has immunomodulatory effects. A number of studies have shown that a variety of combination therapies have been carried out on the basis of Lenvatinib, and exciting outcome has been achieved by combined therapy regimens, including local therapy combined with systemic therapy and multi-drugs systemic therapy.

Neoadjuvant therapy will performe on CNLC stage IB and Stage IIA HCC patients with high risk of recurrence (patients with narrow or no surgical margin and preoperative tumor marker AFP+PIVKA≥1600). MPR, pCR,1-year recurrence-free survival (RFS), and treatment-related adverse reactions (TRAE) were evaluated. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Lenvatinib
• Oxaliplatin
• Recurrence
• TACE

• NCT number: NCT05920863
• Study type: Interventional
• Source: Zhejiang Cancer Hospital
• Contact: Yuhua Zhang, MD
• Phone: +86-0571-88128058
• Email: drzhangyuhua@126.com
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2023
• Completion date: March 2026