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A non-inferior randomized controlled trial of microsphere TAE versus conventional TACE in the treatment of unresectable, intermediate-stage hepatocellular carcinoma

A non-inferior randomized controlled trial of microsphere TAE versus conventional TACE in the treatment of unresectable, intermediate-stage hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059929
Enrollment
Unknown
Registered
2022-05-13
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Hepatocellular Carcinoma

Interventions

cTACE treatment group:cTACE
Microsphere TAE treatment group:Microsphere TAE

Sponsors

Zhongshan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Clinically or pathologically diagnosed as hepatocellular carcinoma; 2. Middle stage liver cancer that cannot be resected; 3. At least one measurable target lesion; 4. ECOG score 0-2 points; 5. Liver function status is Child-Pugh A or B7; 6. The expected life is at least 3 months; 7. Age>18 years old, = 85 years old, gender unlimited; 8. Peripheral blood WBC>3 X 10 * 9/L; 9. Platelet count = 75 X 10 * 9/L; 10. Total bilirubin concentration = 2 mg/dl; 11. Serum albumin = 28 g/L; 12. ALT and AST = 5 times the upper limit of normal value (ULN); 13. Serum creatinine = 1.5 times of ULN.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled infection; 2. Cholangiocarcinoma or mixed cell carcinoma, combined with other tumors; 3. History of drug allergy; 4. HIV infection; 5. Pregnancy; 6. Within the first 30 days, severe bleeding symptoms or clear gastrointestinal bleeding tendency (stool occult blood++and above can not be included in the group); 7. Targeting and immunotherapy have been used before enrollment.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
OS;PFS;TTP;AFP response;DCR;Safety;

Countries

China

Contacts

Public ContactChen Rongxin

Zhongshan Hospital of Fudan University

rongxinchen99@126.com+86 13916988702

Outcome results

None listed

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