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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,500
Receive thymosin-alpha 1 1.6mg with subcutaneous injection, twice a week, for 6 months after radical resection.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITING3-year disease-free survival rate
percentage of patients who have no recurrence or metastases or death at 3 years after surgery.
Time frame: 3 years
3-year overall survival rate
percentage of patients who are alive at 3 years after surgery.
Time frame: 3 years
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
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.