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

Official title

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

Overview

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).

Detailed description

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).

Interventions

• Drug 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.
• Drug 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.

Primary outcome measures

• Progression free survival (PFS) [Time frame: 3 years]

Secondary outcome measures (4)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT06397235 · MIIR-19

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗