NCT05263219

Brief 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).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2026

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

4 years

First QC Date

February 12, 2022

Last Update Submit

June 19, 2023

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaTransarterial chemoembolizationHepatic arterial infusion chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    The time from date of randomization to death due to any cause.

    4 years.

Secondary Outcomes (8)

  • Objective response rate (ORR) per mRECIST.

    4 years.

  • ORR per RECIST 1.1.

    4 years.

  • Disease control rate (DCR) per mRECIST.

    4 years.

  • DCR per RECIST 1.1.

    4 years.

  • Progression free survival (PFS) per mRECIST.

    4 years.

  • +3 more secondary outcomes

Study Arms (2)

Transarterial chemoembolization with drug-eluting beads plus hepatic arterial infusion chemotherapy

EXPERIMENTAL

Patients will receive the combination treatment of DEB-TACE and HAIC.

Procedure: dTACE-HAICDrug: dTACE-HAIC protocol

Hepatic arterial infusion chemotherapy

ACTIVE COMPARATOR

Patients will receive HAIC treatment alone.

Procedure: HAICDrug: HAIC protocol

Interventions

dTACE-HAICPROCEDURE

For DEB-TACE, superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, in order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the proper/left/right hepatic artery. The FOLFOX-based regimen is intra-arterially administered. During follow-up, the treatment will be repeated on demand (at a 4-6-week interval usually) based on the evaluation of the follow-up laboratory and imaging examination.

Transarterial chemoembolization with drug-eluting beads plus hepatic arterial infusion chemotherapy
HAICPROCEDURE

HAIC treatment is divided into 3-week cycles. The microcatheter is advanced into the proper/left/right hepatic artery on day 1 in every cycle of treatment. After the patient returned to the ward, the FOLFOX-based regimen is intra-arterially administered though the microcatheter. The treatment is repeated once every 3 weeks for up to six cycles.

Hepatic arterial infusion chemotherapy
dTACE-HAIC protocolDRUG

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. FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h.

Also known as: Drugs for DEB-TACE and HAIC
Transarterial chemoembolization with drug-eluting beads plus hepatic arterial infusion chemotherapy
HAIC protocolDRUG

FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h.

Also known as: Drugs for HAIC
Hepatic arterial infusion chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Kangshun Zhu, Dr.

    Second Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Central Study Contacts

Mingyue Cai, Dr.

CONTACT

+86-20-34156205cai020@yeah.net

Kangshun Zhu, Dr.

CONTACT

+86-20-34156205zhksh010@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2022

First Posted

March 2, 2022

Study Start

February 10, 2022

Primary Completion

February 9, 2026

Study Completion

February 9, 2026

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

CN(1)