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Trial · Interventional

RecruitingPhase 3Registry data

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

NCTNCT05086614 (opens ClinicalTrials.gov in a new tab)Other idTARCRC
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
2,500 participants (estimated)
Sponsor
Fudan University · Other
Design
Randomized · Single masking
Countries
1 country

China

Start
1 Apr 2021
Primary completion
31 Mar 2027 (estimated)
Completion
31 Mar 2027 (estimated)
First posted
21 Oct 2021
Last update posted
21 Oct 2021
Conditions
Stage II Colorectal Cancer · Stage III Colorectal Cancer

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202420262028
  1. Ph 3

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

    NCT05086614

    1 Apr 2021 to est. 31 Mar 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Thymosin Alpha1Drug

Arms2

  • Experimental

    Thymosin

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

  • No intervention

    Observe

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 3-year disease-free survival rate

    Time frame · 3 years

    Registry description

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

Secondary outcomes(2)

  1. 3-year overall survival rate

    Time frame · 3 years

    Registry description

    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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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