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

Primary Purpose

Stage II Colorectal Cancer, Stage III Colorectal Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Thymosin Alpha1
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage II Colorectal Cancer focused on measuring colorectal cancer, adjuvant treatment, thymosin-alpha 1, disease-free survival

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Thymosin

Observe

Arm Description

Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection.

Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

3-year overall survival rate
percentage of patients who are alive at 3 years after surgery.
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

Full Information

First Posted
September 23, 2021
Last Updated
October 7, 2021
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05086614
Brief Title
Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II Colorectal Cancer, Stage III Colorectal Cancer
Keywords
colorectal cancer, adjuvant treatment, thymosin-alpha 1, disease-free survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection were randomly allocated to receive thymosin-alpha 1 or not in a 1:1 ratio.
Masking
Outcomes Assessor
Masking Description
There is no masking for participants or investigators. The outcomes assessors will be blind for the allocation.
Allocation
Randomized
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thymosin
Arm Type
Experimental
Arm Description
Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection.
Arm Title
Observe
Arm Type
No Intervention
Arm Description
Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection.
Intervention Type
Drug
Intervention Name(s)
Thymosin Alpha1
Other Intervention Name(s)
Thymalfasin
Intervention Description
Receive thymosin-alpha 1 1.6mg with subcutaneous injection, twice a week, for 6 months after radical resection.
Primary Outcome Measure Information:
Title
3-year disease-free survival rate
Description
percentage of patients who have no recurrence or metastases or death at 3 years after surgery.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
3-year overall survival rate
Description
percentage of patients who are alive at 3 years after surgery.
Time Frame
3 years
Title
rate of adverse events related to thymosin-alpha 1
Description
percentage of patients with adverse events related to thymosin-alpha 1, including fever, allergies, skin rash, liver and kidney damage
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 immune-promoting drugs Pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Xu, Dr.
Phone
+86-021-64041990
Email
xujmin@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qingyang Feng, Dr.
Phone
+86-021-64041990
Email
fqy198921@163.com
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu, Dr.
Phone
+86-021-64041990
Email
xujmin@aliyun.com
First Name & Middle Initial & Last Name & Degree
Qingyang Feng, Dr.
Phone
+86-021-64041990
Email
fqy198921@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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