NCT05086614 Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer
| NCT ID | NCT05086614 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Stage II Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,500 participants in total. It began in 2021-04-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05086614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Stage II Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05086614 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,500 participants.
Is NCT05086614 currently recruiting?
Yes, NCT05086614 is actively recruiting participants. Contact the research team at xujmin@aliyun.com for enrollment information.
Where is the NCT05086614 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05086614 clinical trial?
NCT05086614 is sponsored by Fudan University. The trial plans to enroll 2,500 participants.
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