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

NCT ID: NCT05086614

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Stage II Colorectal Cancer Stage III Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
There is no masking for participants or investigators. The outcomes assessors will be blind for the allocation.

Study Groups

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Thymosin

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

Group Type EXPERIMENTAL

Thymosin Alpha1

Intervention Type DRUG

Receive thymosin-alpha 1 1.6mg with subcutaneous injection, twice a week, for 6 months after radical resection.

Observe

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Thymosin Alpha1

Receive thymosin-alpha 1 1.6mg with subcutaneous injection, twice a week, for 6 months after radical resection.

Intervention Type DRUG

Other Intervention Names

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Thymalfasin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianmin Xu, Dr.

Role: CONTACT

[email protected]
+86-021-64041990

Qingyang Feng, Dr.

Role: CONTACT

[email protected]
+86-021-64041990

Facility Contacts

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Jianmin Xu, Dr.

Role: primary

[email protected]
+86-021-64041990

Qingyang Feng, Dr.

Role: backup

[email protected]
+86-021-64041990

Other Identifiers

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TARCRC

Identifier Type: -

Identifier Source: org_study_id