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Cola

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. 12/8 mg (weight ≥ 60kg / \< 60 kg) of Lenvatinib once daily after HAIC. PD-1 inhibitors injection intravenously or percutaneously before 24h of HAIC every 4 week.

12/8 mg (weight ≥ 60kg / \< 60 kg) of Lenvatinib once daily. PD-1 inhibitors injection intravenously or percutaneously every 4 week.

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.

HAIC

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

Lenvatinib 1

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

PD-1 Inhibitors

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

Lenvatinib 2

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

PD-1 inhibitors 2

Xiaodong Wang, MD

Xiaodong Wang, Dr.

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy combined with Lenvatinib and PD-1 inhibitors compared to Lenvatinib plus PD-1 inhibitors for advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT).

Hepatic arterial infusion chemotherapy (HAIC) can significantly improve the local drug concentration in liver compared to systemic chemotherapy. The efficacy of HAIC for hepatocellular (HCC), cholangiocarcinoma, gallbladder, and colorectal carcinoma liver metastasis has been proved by many published studies. HAIC with oxaliplatin and 5-fluorouracil could significantly prolong survival time for HCC patients with portal vein tumor thrombosis (PVTT). Lenvatinib, as a new oral anti-neovascularity inhibitor, was proved to have similar efficacy in HCC patients compared to sorafenib in REFLECT study. The sub-group analysis showed that the median overall survival (OS) in Lenvatinib group was significantly longer that sorafenib group in Chinese HCC patients. Recently, the programmed death-1 (PD-1) inhibitors alone or combined with targeted therapy was explored and confirmed to be effective for advanced HCC, with the median progression-free survival (PFS) and median OS of 2.1-5.6 months and 14.4-22.1 months, resepectively. Thus, the investigators carried out this prospective controlled trial to compare the efficacy and safety of HAIC combined with Lenvatinib and PD-1 inhibitors and Lenvatinib and PD-1 inhibitors for advanced HCC with PVTT.

Total 66 subjects will be recruited in this trial, each group of 33 subjects in treatment group (HAIC-Cola group) and control group (Cola group). The primary endpoint is six-month progression-free survival rate, and the secondary endpoints are OS, overall response rate (ORR), PFS, time-to-progression (TTP) and safety. The safety evaluation will be carried out according to the standard of adverse reaction classification (Common Terminology Criteria for Adverse Events, CTCAE v5.0).

HAIC Combine With Lenvatinib and PD-1 Inhibitors for Advanced HCC With PVTT

Hepatic Arterial Infusion Chemotherapy Combine With Lenvatinib and PD-1 Inhibitors for Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis.

Proportion of patients with 6- month progression-free survival after treatment begining in all patients.

The time from treatment initiation to death due to any cause

The proportion of participants in the analysis population who have complete response (CR) or partial response (PR) determined by investigators using mRECIST criteria at any time during the study.

The time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs firstly.

Time to progression is defined as time from treatment initiation to radiological progression.

Number of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE) assessed by CTCAE v5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
HAIC Combine With Lenvatinib and PD-1 Inhibitors for Advanced HCC With PVTT	NCT05166239	Hepatocellular ... Portal Vein Thr...	HAIC Lenvatinib 1 PD-1 Inhibitors Lenvatinib 2 PD-1 inhibitors...	18 Years - 80 Years	Peking University
HAIC Combine With Lenvatinib and PD-1 Inhibitors for Advanced HCC With PVTT	NCT05166239	Hepatocellular ... Portal Vein Thr...	HAIC Lenvatinib 1 PD-1 Inhibitors Lenvatinib 2 PD-1 inhibitors...	18 Years - 80 Years	Peking University

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