M-TACE Treatment for Unresectable Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Lipiodol Combined With Microspheres TACE for Unresectable HCC

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05875558
• Other study ID #: 2022-ZS-IR-06
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2023
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: July 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• M-TACE
Lipiodol combined with microspheres

Locations

Country	Name	City	State
China	Department of Interventional Radiology, Zhongshan Hospital, Fudan University.	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective response rate according to the mRECIST	1 month after first mTACE
Primary	ORR	Objective response rate according to the mRECIST	3 months after first mTACE
Secondary	OS	Overall survival	1 year
Secondary	OS	Overall survival	3 years