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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05086614
• Other study ID #: TARCRC
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Stage II Colorectal Cancer
• Stage III Colorectal Cancer

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