M-TACE Treatment for Unresectable Hepatocellular Carcinoma

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Primary Purpose

Status

Enrolling by invitation

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

M-TACE

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18≤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. Exclusion Criteria: 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.

Sites / Locations

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

M-TACE

Arm Description

Outcomes

Primary Outcome Measures

ORR

Objective response rate according to the mRECIST

ORR

Objective response rate according to the mRECIST

Secondary Outcome Measures

OS

Overall survival

OS

Overall survival

Full Information

NCT ID

NCT05875558

First Posted

May 11, 2023

Last Updated

May 24, 2023

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05875558

Brief Title

M-TACE Treatment for Unresectable Hepatocellular Carcinoma

Official Title

Lipiodol Combined With Microspheres TACE for Unresectable HCC

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

M-TACE

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

M-TACE

Intervention Description

Lipiodol combined with microspheres

Primary Outcome Measure Information:

Title

ORR

Description

Objective response rate according to the mRECIST

Time Frame

1 month after first mTACE

Title

ORR

Description

Objective response rate according to the mRECIST

Time Frame

3 months after first mTACE

Secondary Outcome Measure Information:

Title

OS

Description

Overall survival

Time Frame

1 year

Title

OS

Description

Overall survival

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 18≤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. Exclusion Criteria: 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.

Facility Information:

Facility Name

Department of Interventional Radiology, Zhongshan Hospital, Fudan University.

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

No

Hepatocellular Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial