Drug-eluting Bead Transarterial Chemoembolization Compared With Conventional Transarterial Chemoembolization as the Conversion Therapy for Unresectable Large Hepatocellular Carcinoma: a Multicenter, Prospective, Nonrandomized Study

  • STATUS
    Recruiting
  • End date
    Jul 8, 2024
  • participants needed
    216
  • sponsor
    Second Affiliated Hospital of Guangzhou Medical University
Updated on 16 October 2022

Summary

This study is conducted to evaluate the efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) compared with conventional transarterial chemoembolization (cTACE) as the conversion therapy for unresectable large hepatocellular carcinoma (HCC).

Description

This is a multicenter, prospective and nonrandomized study to evaluate the efficacy of DEB-TACE (with DC Bead) compared with cTACE as the conversion therapy for unresectable large HCC.

At least 216 patients (≥ 108 patients in each arm) with initially unresectable large HCC (> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE or cTACE as the primary treatment according to their won will. TACE can be repeated on demand based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team, and the technique method of each TACE procedure (i.e. DEB-TACE or cTACE) for the same patient should be consistent. 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 success rate of conversion to resection. The secondary endpoints are objective response rate (ORR) of TACE, progression-free survival (PFS), times of TACE procedure to achieve conversion, conversion time, success rate of surgical resection, tumor recurrence rate after resection, tumor-free survival (TFS) of patients who undergo surgical resection, adverse events (AEs) and overall survival (OS).

Details
Condition Hepatocellular Carcinoma Non-resectable
Treatment Drug-eluting bead transarterial chemoembolization (DEB-TACE), Conventional transarterial chemoembolization (cTACE)
Clinical Study IdentifierNCT04967482
SponsorSecond Affiliated Hospital of Guangzhou Medical University
Last Modified on16 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Hepatocellular carcinoma confirmed by histopathology and/or cytology, or diagnosed clinically
The tumor lesion was only localized in one liver lobe
Large HCC with single lesion > 7 cm, or multiple lesions
unresectable HCC evaluated by the surgeon team
The patient is suitable for TACE treatment, which is evaluated by MDT
At least one measurable intrahepatic target lesion
Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A
ECOG score of performance status ≤ 1 point
Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×109/L, absolute value of neutrophils >1.5×109/L, hemoglobin ≥85 g/L, total bilirubin ≤30 μmol/L, albumin ≥35 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range
Patients have the willingness to receive TACE as the conversion therapy for surgical resection

Exclusion Criteria

Accompanied with tumor thrombus involving the main portal vein, first-order branch or bilateral branches of portal vein
Accompanied with hepatic vein and vena cava tumor thrombus
The extent of the lesion exceeds one liver lobe or extrahepatic metastasis
Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy
Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE treatment and surgical hepatectomy
History of other malignancies
Uncontrollable infection
Patients with active hepatitis B must undergo antiviral therapy to control HBV-DNA <10^3 IU/mL
HCV patients need to complete the anti-HCV therapy before they are enrolled
History of HIV
Allergic to the drugs involved in the research
Patients with gastrointestinal bleeding within 30 days, or other bleeding> CTCAE grade 3\
History of organ or cells transplantation. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy, or systemic therapy
Those with bleeding tendency
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