Actively Recruiting
The Efficacy and Safety of Thymosin-alpha 1 for Adjuvant Treatment After Radical Surgery in High-risk Stage II and III Colorectal Cancer
Led by Fudan University · Updated on 2021-10-21
2500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating thymosin-alpha 1 as an additional treatment for patients with high-risk stage II and stage III colorectal cancer who have undergone radical surgery. Despite surgery and postoperative chemotherapy or radiotherapy, 30-40% of these patients experience cancer recurrence or spread. This study aims to verify the safety and effects of thymosin-alpha 1 in helping to improve immune response and potentially reduce cancer recurrence and metastasis. Participants are randomly assigned to one of two groups: one group receives thymosin-alpha 1 injections twice a week for six months after surgery, while the other group does not receive this treatment. Both groups continue to receive chemotherapy or radiotherapy according to standard Chinese guidelines. The main goal is to compare the disease-free survival rate over three years between the groups. During the study, participants will be monitored regularly for outcomes such as cancer recurrence, overall survival, and any side effects related to thymosin-alpha 1 treatment over a six-month period. The total study duration includes a three-year follow-up to assess long-term effects. Patients will undergo clinical assessments and tests to evaluate their health and response to treatment throughout the study period.
CONDITIONS
Brief Title
Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Colorectal cancer patients who have undergone radical resection
- Pathologically diagnosed with high-risk stage II or stage III colorectal cancer
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Adequate liver, kidney, and blood function
You will not qualify if you...
- Previous use of any immune-promoting drugs
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive thymosin-alpha 1 by subcutaneous injection twice a week for 6 months after radical surgery, alongside chemo/radiotherapy according to standard care.
Twice weekly visits for injections
Duration - 3 years
Participants are monitored for disease-free survival and overall health outcomes for up to 3 years after treatment.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jianmin Xu, Dr.
Q
Qingyang Feng, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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