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
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
Zhejiang Cancer Hospital
35 participants
Jul 1, 2023
INTERVENTIONAL
Conditions
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)
Eligibility
Plain Language Summary
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Interventions
TACE: pharmorubicin 30mg, oxaliplatin 50mg, cycle 4-5 week.
Tislelizumab: 200mg, cycle 3 week. Lenvatinib: weight \<60kg, 8mg/day; weight ≥60kg, 12mg/day.
Locations(1)
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NCT05920863