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NCT05086614RecruitingPhase 3

Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III 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

Source: ClinicalTrials.gov · Last updated 21 Oct 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2500 (estimated)
First submitted
23 Sept 2021
Start date
1 Apr 2021
Primary completion date
31 Mar 2027
Lead sponsor
Fudan University
NCT number
NCT05086614

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 2500
  • From 1 Apr 2021 to the primary completion date, 31 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Had previously taken any immune-promoting drugs

Other

  • Pregnancy or lactation

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongshan Hospital,Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.