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Effect of Perioperative Immune Status and Long-term Prognosis of Thymosin Alpha-1 for Injection(Zadaxin) in Treatment of Patients with Colorectal Cancer: A Prospective, Randomized Controlled Trial

Effect of Perioperative Immune Status and Long-term Prognosis of Thymosin Alpha-1 for Injection(Zadaxin) in Treatment of Patients with Colorectal Cancer: A Prospective, Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055819
Enrollment
Unknown
Registered
2022-01-20
Start date
2022-01-16
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

Test group:Thymosin Alpha-1 subcutaneous injection
Control group:without Thymosin alpha-1

Sponsors

The Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 75 years old, regardless of gender; 2.Adenocarcinoma was confirmed by pathology before operation; 3.Imaging evaluation of tumor resectability; 4.Preoperative chest and abdominal CT examination was performed to determine the tumor stage and exclude distant metastasis; 5.ECoG score 70, can tolerate neoadjuvant chemotherapy and surgery after evaluation; 6.No radiotherapy and chemotherapy for tumor before randomization; 7.Laboratory index requirements: HB >= 90g/L (no blood transfusion within 14 days), ANC >= 1.5 x 10^9/L, PLT >= 80 x 10^9/L, TBIL 50ml / min. 8.Sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Multiple primary colorectal cancer; 2.The patient refused surgery and immunomodulator treatment; 3.The tumor cannot be removed; 4.Confirmed or suspected tumor metastasis; 5.ECoG score >= 2 or KPS score <= 70, physical condition can not tolerate chemotherapy or surgery; 6.The patient has signs of peritonitis or intestinal perforation and needs emergency surgical treatment; 7.Other reviewers believe that there are sufficient reasons for disqualification from the registration study: if there is potential nonconformity with the clinical protocol.

Design outcomes

Primary

MeasureTime frame
CD4 / CD8 ratio;CRP;PLR;NLR;1-year DFS;3-year DFS;2-year OS;

Countries

China

Contacts

Public ContactNiu Wenbo

The Fourth Hospital of Hebei Medical University

nwblzy125@163.com+86 15831183883

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026