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
1 other identifier
interventional
2,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2021
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 23, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
October 21, 2021
March 1, 2021
6 years
September 23, 2021
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year disease-free survival rate
percentage of patients who have no recurrence or metastases or death at 3 years after surgery.
3 years
Secondary Outcomes (2)
3-year overall survival rate
3 years
rate of adverse events related to thymosin-alpha 1
6 months
Study Arms (2)
Thymosin
EXPERIMENTALPatients with pathological high-risk stage II and stage III colorectal cancer after radical resection.
Observe
NO INTERVENTIONPatients with pathological high-risk stage II and stage III colorectal cancer after radical resection.
Interventions
Receive thymosin-alpha 1 1.6mg with subcutaneous injection, twice a week, for 6 months after radical resection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Had previously taken any immune-promoting drugs
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- There is no masking for participants or investigators. The outcomes assessors will be blind for the allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2021
First Posted
October 21, 2021
Study Start
April 1, 2021
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
October 21, 2021
Record last verified: 2021-03