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

NCT05086614 · tracked via the Priya Life Science China tracker

Sponsor

Fudan University

Phase

Phase 3

Started

2021-04-01

Last updated

2021-10-21

Condition(s) studied

Stage II Colorectal CancerStage III Colorectal Cancer

Investigational drug(s) / intervention(s)

Thymosin Alpha1 →

Thymosin Alpha1: Receive thymosin-alpha 1 1.6mg with subcutaneous injection, twice a week, for 6 months after radical resection.

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * Had previously taken any immune-promoting drugs * Pregnancy or lactation

Primary outcome measure(s)

3-year disease-free survival rate — 3 years
percentage of patients who have no recurrence or metastases or death at 3 years after surgery.

Trial sites (1)

Facility	City	Region	Status
Zhongshan Hospital, Fudan University	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05086614 on ClinicalTrials.gov ↗ ← All trials in China