RecruitingPhase 3NCT05086614

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

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


Sponsor

Fudan University

Enrollment

2,500 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • Colorectal cancer receiving radical resection
  • Pathologically diagnosed with high-risk stage II or stage III
  • Eastern Cooperative Oncology Group performance status of 0-2
  • Adequate hepatic, renal, and hematologic function

Exclusion Criteria2

  • Had previously taken any immune-promoting drugs
  • Pregnancy or lactation

Interventions

DRUGThymosin Alpha1

Receive thymosin-alpha 1 1.6mg with subcutaneous injection, twice a week, for 6 months after radical resection.


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT05086614


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