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NCT Number: NCT05086614

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

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Key information

Conditions

Stage II Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Stage III Colorectal Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thymosin Alpha1

Drug

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

Other names: Thymalfasin

Primary outcomes

  1. 3-year disease-free survival rate

    Time frame: 3 years

    percentage of patients who have no recurrence or metastases or death at 3 years after surgery.

Secondary outcomes

  1. 3-year overall survival rate

    Time frame: 3 years

    percentage of patients who are alive at 3 years after surgery.

  2. rate of adverse events related to thymosin-alpha 1

    Time frame: 6 months

    percentage of patients with adverse events related to thymosin-alpha 1, including fever, allergies, skin rash, liver and kidney damage

Study contacts

Contact information is provided by the study sponsor or research team.

Jianmin Xu, Dr.

CONTACT

[email protected]

+86-021-64041990

Qingyang Feng, Dr.

CONTACT

[email protected]

+86-021-64041990

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Oct 21, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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