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

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.

Study Overview

• Status: Recruiting
• Conditions: Stage III Colorectal Cancer; Stage II Colorectal Cancer
• Intervention / Treatment: Drug: Thymosin Alpha1

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 Type: Interventional
• Enrollment (Anticipated): 2500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jianmin Xu, Dr.; Phone Number: +86-021-64041990; Email: xujmin@aliyun.com
• Study Contact Backup: Name: Qingyang Feng, Dr.; Phone Number: +86-021-64041990; Email: fqy198921@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Jianmin Xu, Dr.; Phone Number: +86-021-64041990; Email: xujmin@aliyun.com
      • Contact: Qingyang Feng, Dr.; Phone Number: +86-021-64041990; Email: fqy198921@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thymosin; Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection.	Drug: Thymosin Alpha1; Receive thymosin-alpha 1 1.6mg with subcutaneous injection, twice a week, for 6 months after radical resection.; Other Names: Thymalfasin
No Intervention: Observe; Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): March 31, 2027
• Study Completion (Anticipated): March 31, 2027

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: colorectal cancer; adjuvant treatment; disease-free survival; thymosin-alpha 1
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Thymalfasin
• Other Study ID Numbers: TARCRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No