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Comparative and multicenter study between Doxorubicin (Epirubicin\Pirarubicin)-eluting beads and conventional transarterial chemoembolization for treatment of advanced and unresectable hepatocellular carcinoma

Comparative and multicenter study between Doxorubicin (Epirubicin\Pirarubicin)-eluting beads and conventional transarterial chemoembolization for treatment of advanced and unresectable hepatocellular carcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONN-16010202
Enrollment
Unknown
Registered
2016-12-21
Start date
2016-08-20
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Hepatocellular carcinoma

Interventions

DEB-TACE group:Doxorubicin(Epirubicin\Pirarubicin)-eluting beads (CalliSpheres) TACE
cTACE group:conventional (microspheres plus lipiodol-doxorubicin) TACE

Sponsors

The First Hospital Affiliated to Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 75, male or female; 2. Histopathological or clinical diagnosis of hepatocellular carcinoma( Reference for the updating of clinical guidelines for hepatocellular carcinoma released by AASLD in 2010); 3. Advanced and unresectable hepatocellular carcinoma,a single nodule or less than 3 tumor nodules, and the nodule size is less than 7cm; 4. Primary tumors have not been treated or without intervention (TACE, iodine therapy) in a year or recurrence after surgery / ablation; 5. Expected survival time is longer than three months; 6. Good liver function (Child-Pugh grade A or grade B for 7 points), hematology index and renal function is normal; 7. ECOG score is less than or equal to 1 point; 8. Understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Distant metastasis of tumor; 2. TACE or iodine particle therapy within a year; 3. Obvious arteriovenous fistula; 4. Patients who have had or are now concurrent with other malignant tumors (except for those that have been cured of basal or squamous cell skin cancer or cervical carcinoma in situ); 5. A major disease history of the heart, kidney, bone marrow, or lung, central nervous system involvement; 6. Patients who need antibiotic therapy due to the recent infection; 7. Patients who participate other clinical trials of drugs or devices within four weeks; 8. Complications or social environment that can lead to the failure of the subjects to follow the study plan and even endanger the safety of the patients.

Design outcomes

Primary

MeasureTime frame
RR;DCR;

Secondary

MeasureTime frame
OS;TTP;THP;TEP;DQOL;

Countries

China

Contacts

Public ContactJunhui Sun

The First Hospital Affiliated to Zhejiang University

sunjh121@163.com+86 13575725162

Outcome results

None listed

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