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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Stage II Colorectal Cancer, Stage III Colorectal Cancer

Intervention / Treatment
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* Drug: Thymosin Alpha1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection were randomly allocated to receive thymosin-alpha 1 or not in a 1:1 ratio.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thymosin<br>Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection. | Drug: Thymosin Alpha1<br>* Receive thymosin-alpha 1 1.6mg with subcutaneous injection, twice a week, for 6 months after radical resection.<br>* Other names: Thymalfasin;|
| No Intervention: Observe<br>Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival rate | percentage of patients who are alive at 3 years after surgery. | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, adjuvant treatment, thymosin-alpha 1, disease-free survival