bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC

Официальное название

Sequential bTAE-HAIC Combined With Lenvatinib and Camrelizumab for Intermediate-advanced Huge Hepatocellular Carcinoma

Обзор

This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with intermediate-advanced huge hepatocellular carcinoma.

Подробное описание

Blank-microsphere transcatheter arterial embolization (bTAE) and hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. Lenvatinib is non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. Camrelizumab, a programmed cell death protein-1 (PD-1) inhibitor, is effective and tolerable in patients with unresectable hepatocellular carcinoma. No study has evaluated bTAE-HAIC plus Lenvatinib and Camrelizumab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Вмешательства

• Процедура bTAE-HAIC
  bTAE procedure was a 2.8-F microcatheter was superselectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). The microcatheter was reserved at the proper/left/right hepatic artery according tumor location. After the patient returned to the ward, the following FOLFOX-based regime was intra-arterially administered through the microcatheter. The FOLFOX regi
• Препарат Lenvatinib
  12 mg (or 8 mg) once daily (QD) oral dosing.
• Препарат Camrelizumab
  200mg intravenously every 2 weeks

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Progression free survival (PFS) [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Clinical diagnosis of HCC.
• Age between 18 and 75 years;
• The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;
• Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (≤5).
• Child-Pugh class A or B;
• Eastern Cooperative Group performance status (ECOG) score of 0-2;
• Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
• Prothrombin time ≤18s or international normalized ratio < 1.7.
• Ability to understand the protocol and to agree to and sign a written informed consent document.

Критерии исключения

• Diffuse HCC;
• Extrahepatic metastasis >5;
• Obstructive PVTT involving the main portal vein.
• Serious medical comorbidities.
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of bleeding diathesis.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Guanzhou

Идентификаторы

NCT: NCT06061276 · Liver Project 3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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