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Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer

Stage III Colorectal Cancer Clinical Trial

Official title:
The Efficacy and Safety of Thymosin-alpha 1 Used for Adjuvant Treatment After Radical Resection of High-risk Stage II and Stage III Colorectal Cancer

Clinical Trial Summary

For high-risk stage II and stage III colorectal cancer, even after radical resection and postoperative adjuvant chemo/radiotherapy, 30-40% of patients will still have recurrence and metastasis. Thymosin-alpha 1 is believed to improve immunity and may help promote tumor immunity to reduce the incidence of recurrence and metastasis. This study hopes to verify the effecacy and safety of thymosin-alpha 1 for adjuvant treatment of high-risk stage II and stage III colorectal cancer after radical resection.

Clinical Trial Description

Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection were randomly allocated to receive thymosin-alpha 1 twice a week for 6 months (experimental group) or not (control group) in a 1:1 ratio. At the same time, all patients will receive chemo/radiotherapy according to the Chinese Standards for Diagnosis and Treatment of Colorectal Cancer. The primary endpoint is 3-year DFS rate. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05086614
Study type Interventional
Source Fudan University
Contact Jianmin Xu, Dr.
Phone +86-021-64041990
Email xujmin@aliyun.com
Status Recruiting
Phase Phase 3
Start date April 1, 2021
Completion date March 31, 2027
View Details
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