DEB-TACE+HAIC vs. HAIC for Large HCC

  • STATUS
    Recruiting
  • End date
    Feb 9, 2026
  • participants needed
    230
  • sponsor
    Second Affiliated Hospital of Guangzhou Medical University
Updated on 10 March 2022

Summary

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

Description

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

230 patients with initially unresectable large HCC (> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE plus HAIC (dTACE-HAIC) or HAIC as the primary treatment using an 1:1 randomization scheme. In the dTACE-HAIC arm, the microcatheter will be reserved at the proper/left/right hepatic artery and chemotherapy drugs (FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. The treatment can be repeated on demand (at a 4-6-week interval usually) based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the HAIC arm, treatment will repeated once every 3 weeks for up to six cycles. 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 overall survival (OS). The secondary endpoints are tumor response (objective response rate and disease control rate), success rate of conversion to resection, progression-free survival (PFS), and adverse events (AEs).

Details
Condition Unresectable Hepatocellular Carcinoma
Treatment HAIC, dTACE-HAIC, dTACE-HAIC protocol, HAIC protocol
Clinical Study IdentifierNCT05263219
SponsorSecond Affiliated Hospital of Guangzhou Medical University
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with HCC confirmed by histology/cytology or diagnosed clinically
The maximum HCC lesion > 7 cm
Unresectable HCC evaluated by the surgeon team
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 ≥75×10^9/L, leukocyte >3.0×10^9/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range
Life expectancy of at least 3 months

Exclusion Criteria

Accompanied with tumor thrombus involving the main portal vein or bilateral first-order branch of portal vein
Accompanied with vena cava tumor thrombus
Extrahepatic metastasis
Previous treatment with TACE, HAIC, liver transplantation, resection, ablation, radiotherapy, or systemic therapy
Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy
Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE or HAIC treatment
History of other malignancies
Uncontrollable infection
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
Those with bleeding tendency
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