Enhanced Immunotherapy for the Prevention of Postoperative Recurrence of Hepatocellular Carcinoma:A Prospective Multicenter Randomized Controlled Trial

The Effect of Thymosin Alpha 1 in Preventing Recurrence for Small Hepatocellular Carcinoma With High-risk Recurrent Factors Following Radical Resection: A Prospective Multicenter Randomized Controlled Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800014409

Enrollment

Unknown

Registered

2018-01-11

Start date

2018-01-14

Completion date

Unknown

Last updated

2018-01-15

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

Conditions

HBV-related Hepatocellular carcinoma

Interventions

therapy group:Thymosin Alpha 1 (Zadaxin) 1.6mg injection subcutaneously, biw for twenty-four weeks after surgery

control group:none

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. at least one of HBsAg, HBeAg, anti-HBe and anti-HBcis positive; 3. Pathologically proved HCC; 4. 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; 5. solitary tumor =5cm with MVI; up to three nodules =3 cm in diameter(with or without MVI), without extrahepatic metastasis or adjacent organ involvement before surgery; 6. The value of ECOG PS of 0, 1, or 2; 7. Can understand, participate voluntarily and have signed the informed consent of this study; 8. Patients with good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients with known allergic reactions or intolerance to experimental drugs; 2. Pregnant or lactating women; 3. With evidence of extrahepatic metastasis, macroscopic tumor thrombi in portal vein, inferior caval vein or intrahepatic bile ducts; 4. Motality within one month after surgery; 5. With evidence of unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmia, acute myocardial infarction within the last six months, prolonged QT interval (>450ms); 6. With evidence of active infection (NCI-CTCAE version 3.0, >grade two); 7. Usage of other anticancer drugs or immuno-modulating drugs; 8. Too poor condition to be tolerated of the drugs.

Design outcomes

Primary

Measure	Time frame
1-,3-,5-year recurrence free survival and recurrence;	—

Secondary

Measure	Time frame
1-,3-,5-year overall survival;	—

Countries

China

Contacts

Public ContactTianfu Wen

West China Hospital of Sichuan University

wentianfu@scu.edu.cn+86 028 85422871

Outcome results

None listed

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