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The Protective Effect of Thymosin Alpha 1 (Zadaxin) for Small Hepatocellular Carcinoma from Recurrence/Metastasis Following Radical Resection: A Randomised Controlled Prospective Study

The Protective Effect of Thymosin Alpha 1 (Zadaxin) for Small Hepatocellular Carcinoma from Recurrence/Metastasis Following Radical Resection: A Randomised Controlled Prospective Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000588
Enrollment
Unknown
Registered
2009-11-12
Start date
2009-12-01
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

therapy group:Thymosin Alpha 1 (Zadaxin) 1.6mg injection subcutaneously, qd for two days before surgery, tiw for twelve weeks after surgery.
control group:None

Sponsors

Liver Cancer Institute and Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18 to 75 years old male or non-pregnant female hepatocellular carcinoma patient; 2. Radical resection of HCC (defined as completely removal of the tumor and without macroscopic tumor thrombi) for the first time and without other prior antitumor therepies; 3. Pathologically proved HCC, solitary tumor <3cm or two tumors <5cm in diameter, without extrahepatic metastasis or adjacent organ involvement before surgery; 4. Can understand and complete the informed consent of this study.

Exclusion criteria

Exclusion criteria: 1. With evidence of extrahepatic metastasis, macroscopic tumor thrombi in portal vein, inferior caval vein or intrahepatic bile ducts; 2. Motality within one month after surgery; 3. With evidence of unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmia, acute myocardial infarction within the last six months, prolonged QT interval (>450ms); 4. With evidence of active infection (NCI-CTCAE version 3.0, >grade two); 5. Usage of other anticancer drugs or immuno-modulating drugs; 6. Too poor condition to be tolerated of the drugs.

Design outcomes

Primary

MeasureTime frame
1-, 2-, 3-year recurrence free survival and recurrence;

Secondary

MeasureTime frame
1-, 2-, 3-year overall survival;

Countries

China

Contacts

Public ContactJia Fan
jiafan99@yahoo.com+86 21 64037181

Outcome results

None listed

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