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A multicenter, randomized, controlled trial on the efficacy and safety of CalliSpheres drug-loaded microspheres in the treatment of primary liver cancer

A multicenter, randomized, controlled trial on the efficacy and safety of CalliSpheres drug-loaded microspheres in the treatment of primary liver cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017957
Enrollment
Unknown
Registered
2018-08-24
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-08-27

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

Conditions

BCLC-B primary liver cancer

Interventions

group 1:CalliSpheres drug-loaded microspheres would be used
group 2:CalliSpheres drug-loaded microspheres would not be used

Sponsors

the First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age older than 18 years, sex unlimited; (2) Diagnosis of hepatocellular carcinoma; (3) Not suitable for resection or had percutaneous ablation; (4) No chemotherapyradiotherapy?artery embolization or other antitumor therapy; (5) The number of gland of tumor=3; (6) The Child-Pugh of liver function; (7) BCLC-B; (8) ECOG=1; (9) Expected survival time=12 weeks; (10) Informed and signed informed consent paper.

Exclusion criteria

Exclusion criteria: (1) Other primary tumors; (2) Women in gestational and lactational; (3) People who couldnt have measures with contraception; (4) Accumulation of liver tumor>50%; (5) Patients with advanced liver disease; (6) Cant find superselective arterial intro operation; (7) Blood vessel invasion or extrahepatic metastasis; (8) Initial Iodine uptake of arterial phase and portal vein; (9) Cant do MRI; (10) Contraindicantions of DSA?TACE and epirubicin.

Design outcomes

Primary

MeasureTime frame
efficacy of 1, 3, and 6 month;disease control rate;

Secondary

MeasureTime frame
overall survival;Time to progression;

Countries

China

Contacts

Public ContactHongshuang Pan
15840051275@163.com+86 15840051275

Outcome results

None listed

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