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NCT05086614·Phase 3·INTERVENTIONAL

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

Thymosin Alpha-1OtherRecruiting

Status

Recruiting

Phase

Phase 3

Enrollment

2,500

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Thymosin Alpha1

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

Timeline

From registration to results.

  1. First posted

    Oct 21, 2021

  2. Study start

    Apr 1, 2021

  3. Primary completion

    Mar 31, 2027

  4. Study completion

    Mar 31, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Oct 21, 2021

Outcomes

What the study measures.

Primary outcomes

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

3-year overall survival rate

Time frame · 3 years

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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