HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion

Condition(s) studied

Investigational drug(s) / intervention(s)

HAIC: Hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks.

Lenvatinib: 12/8 mg (weight ≥ 60kg / \< 60 kg) of Lenvatinib once daily after HAIC.

PD-1 Inhibitors: PD-1 inhibitors injection intravenously or percutaneously before 24h of HAIC every 4 week

Lenvatinib 1: 12/8 mg (weight ≥ 60kg / \< 60 kg) of Lenvatinib once daily.

PD-1 inhibitors 1: PD-1 inhibitors injection intravenously or percutaneously every 4 week

Study summary

The combination of HAIC with systemic therapy can provide superior efficacy compared to systemic therapy alone or local therapy alone for patients with advanced HCC complicated by vascular invasion, regardless of whether they have extrahepatic metastasis, with overall manageable safety. Currently, guidelines have recommended HAIC for HCC patients with unresectable primary tumors, PVTT type I/II/III/IV, and Child-Pugh A liver function, and recognize that its combination with sorafenib for patients with PVTT has superior efficacy compared to sorafenib monotherapy. However, more evidence is still needed regarding the efficacy of HAIC combined with lenvatinib and PD-1 inhibitors for patients with major vascular invasion (including PVTT/HVTT/IVCTT, etc.) and bile duct invasion. This study aims to further validate the efficacy and safety of lenvatinib and PD-1 inhibitors ± HAIC for HCC patients with major vascular invasion (including PVTT/HVTT/IVCTT, etc.) and bile duct invasion through larger sample size multicenter real-world data, with the goal of providing new evidence-based guidance for HCC treatment in clinical practice. This study is to evaluate the efficacy and safety of HAIC combined with lenvatinib and PD-1 inhibitors versus lenvatinib combined with PD-1 inhibitors in the first-line treatment of advanced hepatocellular carcinoma with major vascular or biliary invasion

Eligibility

Primary outcome measure(s)

• OS — From date of treatment beginning until the date of death from any cause, assessed up to 36 months.
  The time from treatment initiation to death due to any cause

Trial sites (1)

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