NCT05875558

Brief Summary

This study aims to investigate the safety and efficacy of transarterial chenmoembolization（TACE） combined with microspheres for unresectable hepatocellular carcinoma(HCC).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

May 11, 2023

Last Update Submit

May 24, 2023

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • ORR

    Objective response rate according to the mRECIST

    1 month after first mTACE

  • ORR

    Objective response rate according to the mRECIST

    3 months after first mTACE

Secondary Outcomes (2)

  • OS

    1 year

  • OS

    3 years

Study Arms (1)

M-TACE

EXPERIMENTAL
Procedure: M-TACE

Interventions

M-TACEPROCEDURE

Lipiodol combined with microspheres

M-TACE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤Age\<80 on day of signing informed consent.
  • Have histologically confirmed diagnosis or radiological diagnosis of HCC with at least one \>3cm targeted lesion.
  • Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease, BCLC stage A disease but refuse a surgical or ablation therapy.
  • Have a Child-Pugh Class A/B（\<7） liver score.
  • Have a performance status of 0 or 1 using the ECOG.
  • Have a predicted life expectancy of greater than 3 months.

You may not qualify if:

  • The targeted lesions have received TACE or other locoregional therapy within 3 months.
  • Tumor burden over 70% of the liver volume.
  • Lesions can not be measured by mRECIST.
  • Has a diagnosed additional malignancy.
  • Patients with Hb\<9.0g/dL, WBC\<1.0×10\^9/L， TB\>3mg/dL，ALT/AST\>5 UL, ALB\<2.8g/dL， INR\>2.3, Cr \>2mg/mL or CCr\<30mL/min.
  • Severe heart, lung or cerebral disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 25, 2023

Study Start

July 1, 2022

Primary Completion

December 1, 2023

Study Completion

July 1, 2024

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)