M-TACE Treatment for Unresectable Hepatocellular Carcinoma

NCT ID: NCT05875558

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

M-TACE

Group Type EXPERIMENTAL

M-TACE

Intervention Type PROCEDURE

Lipiodol combined with microspheres

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

M-TACE

Lipiodol combined with microspheres

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 18≤Age\<80 on day of signing informed consent.
2. Have histologically confirmed diagnosis or radiological diagnosis of HCC with at least one \>3cm targeted lesion.
3. 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.
4. Have a Child-Pugh Class A/B(\<7) liver score.
5. Have a performance status of 0 or 1 using the ECOG.
6. Have a predicted life expectancy of greater than 3 months.

Exclusion Criteria

1. The targeted lesions have received TACE or other locoregional therapy within 3 months.
2. Tumor burden over 70% of the liver volume.
3. Lesions can not be measured by mRECIST.
4. Has a diagnosed additional malignancy.
5. 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.
6. Severe heart, lung or cerebral disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhiping Yan

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-ZS-IR-06

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.