Using Thymosin-alpha 1 to prevent cancer recurrence after surgery for high-risk colorectal cancer
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
This study is testing if a drug called thymosin-alpha 1 can help prevent cancer from coming back in people with high-risk colorectal cancer after their surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05086614 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of thymosin-alpha 1 as an adjuvant treatment for patients with high-risk stage II and III colorectal cancer following radical resection. Participants will be randomly assigned to receive thymosin-alpha 1 twice a week for six months or to a control group receiving standard care without the drug. All patients will also undergo chemotherapy or radiotherapy as per established guidelines. The primary goal is to evaluate the three-year disease-free survival rate among the participants.
Who should consider this trial
Good fit: Ideal candidates are individuals with high-risk stage II or III colorectal cancer who have undergone radical resection and meet specific health criteria.
Not a fit: Patients who have previously taken immune-promoting drugs or are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of cancer recurrence and metastasis in patients with high-risk colorectal cancer.
How similar studies have performed: While thymosin-alpha 1 has been explored in other contexts, this specific application in high-risk colorectal cancer is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jianmin Xu, Dr.
- Email: xujmin@aliyun.com
- Phone: +86-021-64041990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.