Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 75

Using Thymosin-alpha 1 to prevent cancer recurrence after surgery for high-risk colorectal cancer

Official title: 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

Run by Fudan University · NCT05086614 · Data updated 2026-11-12

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

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment2500 (estimated)
SponsorFudan University
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedApril 1, 2021
Main results expectedMarch 31, 2027
Study endsMarch 31, 2027
Registry record updatedOctober 21, 2021
Trial IDNCT05086614 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients who have previously taken immune-promoting drugs or are pregnant or lactating may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Zhongshan Hospital, Fudan University
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.