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Efficacy and Safety of TACE with CalliSpheres Drug-eluting beads in Patients with Hepatocellular Carcinoma Refractory to Conventional Transcatheter Arterial Chemoembolization

Efficacy and Safety of TACE with CalliSpheres Drug-eluting beads in Patients with Hepatocellular Carcinoma Refractory to Conventional Transcatheter Arterial Chemoembolization

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018241
Enrollment
Unknown
Registered
2018-09-06
Start date
2018-10-01
Completion date
Unknown
Last updated
2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

Sponsors

The First Affiliated Hospital,College of Medicine,Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Understand and sign the informed consent approved by ethics committee 2. Aged 18 to 75 years male or female; 3. Confirmed diagnosis of HCC according to the diagnostic criteria included in the management guideline issued by China's Ministry of Health in 2017; 4. Conform to cTACE resistance standard of HCC 5. Single tumor less than 10cm in diameter or multiple tumors with maximum 5 lesions with >1cm in diameter, individual diameter <5cm; 6. Preserved liver function (Child-Pugh A or B7); 7. ECOG Performance Status 0 or 1.

Exclusion criteria

Exclusion criteria: 1. With arteriovenuous fistula or artery-portal vein fistula; 2. Diffuse HCC with defined as >50% liver involvement; 3. Any contraindication for TACE treatment; 4. Any contraindication for Epirubicin application; 5. Advanced liver disease (bilirubin levels >2 mg/dl, AST or ALT >5 times upper limit of normal); 6. Renal failure or insufficient renal function (Creatinine levels >2 mg/dl); 7. Subject unable to receive MRI examination; 8. Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment; 9. Couldn't commit reliable birth control measures during treatment or within 12 months of treatment; 10. Subject is participating other investigational drug or device clinical trial; 11. Subject is not suitable to participate in the study as judged by investigator; 12. With history of DEB-TACE for HCC.

Design outcomes

Primary

MeasureTime frame
TTP (time-to-progression);

Secondary

MeasureTime frame
OS (overall survival);DCR;ORR;

Countries

China

Contacts

Public ContactGuan-Hui Zhou

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

1512035@zju.edu.cn+86 15167192358

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026