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

Phase 3

Recruiting

• Conditions: Stage II Colorectal Cancer; Stage III Colorectal Cancer
• Interventions: Drug: Thymosin Alpha1

• Registration Number: NCT05086614
• Lead Sponsor: Fudan University

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.

Detailed Description

Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection were randomly allocated to receive thymosin-alpha 1 twice a week for 6 months (experimental group) or not (control group) in a 1:1 ratio. At the same time, all patients will receive chemo/radiotherapy according to the Chinese Standards for Diagnosis and Treatment of Colorectal Cancer. The primary endpoint is 3-year DFS rate.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-04-01
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-07
• Last Update Submitted: 2021-10-07
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thymosin	Thymosin Alpha1	Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection.

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival rate	3 years	percentage of patients who have no recurrence or metastases or death at 3 years after surgery.

Secondary Outcome Measures

Name	Time	Method
3-year overall survival rate	3 years	percentage of patients who are alive at 3 years after surgery.
rate of adverse events related to thymosin-alpha 1	6 months	percentage of patients with adverse events related to thymosin-alpha 1, including fever, allergies, skin rash, liver and kidney damage

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China