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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05086614
Other study ID # TARCRC
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2021
Est. completion date March 31, 2027

Study information

Verified date March 2021
Source Fudan University
Contact Jianmin Xu, Dr.
Phone +86-021-64041990
Email xujmin@aliyun.com
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date March 31, 2027
Est. primary completion date March 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
China Zhongshan Hospital, Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 3-year disease-free survival rate percentage of patients who have no recurrence or metastases or death at 3 years after surgery. 3 years
Secondary 3-year overall survival rate percentage of patients who are alive at 3 years after surgery. 3 years
Secondary rate of adverse events related to thymosin-alpha 1 percentage of patients with adverse events related to thymosin-alpha 1, including fever, allergies, skin rash, liver and kidney damage 6 months
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