Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer
Recruiting
Phase 3
Interventional Study
Stage II Colorectal Cancer
Stage III Colorectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 2,500 (estimated)
- Sponsor
- Fudan University · Other
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About This Trial
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-alph…
Trial Locations
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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 imm…
Contacts