M-TACE Treatment for Unresectable Hepatocellular Carcinoma | NCT05875558

Studies
M-TACE Treatment for Unresectable Hepatocellular Carcinoma

NCT05875558

Sponsor

Shanghai Zhongshan Hospital

Status

Unknown status

Last Update Posted

May 25, 2023Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma

Interventions

M-TACE

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Jul 1, 2024Estimated

First Submitted Date

May 11, 2023

First Submission Date that Met QC Criteria

May 24, 2023

First Posted Date

May 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2023

Last Update Posted Date

May 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
M-TACE	Experimental		Procedure: M-TACE

Name	Type	Description	Arm Group Labels	Other Names
M-TACE	Procedure	Lipiodol combined with microspheres	M-TACE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
OS	Overall survival	1 year
OS	Overall survival	3 years

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Interventional Radiology, Zhongshan Hospital, Fudan University.		Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided