Stage II Colorectal Cancer, Stage III Colorectal Cancer
Conditions
Keywords
colorectal cancer, adjuvant treatment, thymosin-alpha 1, disease-free survival
Brief 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.
Detailed 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.
Interventions
DRUGThymosin Alpha1
Receive thymosin-alpha 1 1.6mg with subcutaneous injection, twice a week, for 6 months after radical resection.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
There is no masking for participants or investigators. The outcomes assessors will be blind for the allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease-free survival rate | 3 years | percentage of patients who have no recurrence or metastases or death at 3 years after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival rate | 3 years | percentage of patients who are alive at 3 years after surgery. |
| rate of adverse events related to thymosin-alpha 1 | 6 months | percentage of patients with adverse events related to thymosin-alpha 1, including fever, allergies, skin rash, liver and kidney damage |
Countries
China
Contacts
Primary ContactJianmin Xu, Dr.
Backup ContactQingyang Feng, Dr.
Outcome results
None listed