DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC

Официальное название

DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial

Обзор

This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).

Подробное описание

This is a multicenter randomized study to evaluate the efficacy and safety of DEB-TACE plus RALOX-HAIC (DEB-TACE+HAIC) compared with DEB-TACE alone for unresectable large HCC (\>7cm).

130 patients with unresectable large HCC (\> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE+HAIC or DEB-TACE using an 1:1 randomization scheme. In the DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery and chemotherapy drugs (RALOX-based regimen) will be intra-arterially administered though the microcatheter. In the DEB-TACE arm, patients will be treated with DEB-TACE alone. The treatments can be repeated on demand (at a 4-week interval usually) based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.

The primary end point of this study is progression-free survival (PFS). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS) , and adverse events (AEs).

Вмешательства

• Препарат DEB-TACE+HAIC
  CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected. RALOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; Raltitrexed, 3 mg/m2 infusion for 0.5 hour.
• Препарат DEB-TACE
  CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected.

Первичные конечные точки

• Progression free survival (PFS) [Срок оценки: 3 years]

Вторичные конечные точки (4)

• Objective response rate (ORR) [Срок оценки: 3 years]
• Disease control rate (DCR) [Срок оценки: 3 years]
• Overall survival (OS) [Срок оценки: 4 years]
• Adverse Events (AEs) [Срок оценки: 3 years]

Критерии участия

Критерии включения

• HCC confirmed by histology/cytology or diagnosed clinically.
• At least one measurable intrahepatic target lesion.
• The largest tumor size > 7 cm.
• Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment.
• Child-Pugh score 5-7.
• ECOG performance status ≤ 1.
• Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte >3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds.

Критерии исключения

• Macrovascular invasion or extrahepatic metastasis.
• Diffuse HCC.
• Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
• Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.
• Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment.
• History of other malignancies.
• Uncontrollable infection.
• History of HIV.
• Gastrointestinal bleeding within 30 days, or other bleeding> CTCAE grade 3.
• History of organ or cells transplantation.
• Pregnant or lactating patients.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Идентификаторы

NCT: NCT06397235 · MIIR-19

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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