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A multi-cohort, open-label, multi-center exploratory study of alogliptin alpha injection for the prevention of neutropenia after two-week chemotherapy in patients with colorectal cancer/pancreatic can

A multi-cohort, open-label, multi-center exploratory study of alogliptin alpha injection for the prevention of neutropenia after two-week chemotherapy in patients with colorectal cancer/pancreatic cancer.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107802
Enrollment
Unknown
Registered
2025-08-19
Start date
2024-02-20
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

Colorectal cancer, mucosal adenocarcinoma

Interventions

Study group:Within 24-48 hours after the end of chemotherapy, injection of Ebergostine a injection

Sponsors

The second affiliated hospital of Zhejiang University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up; 2. Age 18 years and above, male or female; 3. Patients with histologically or cytologically confirmed locally advanced or advanced colorectal and pancreatic cancer, who are planned to receive at least 2 courses of FOLFIRI, FOLFOXIRI or mFOLFIRINOX or a treatment regimen with or without targeted drugs in first-line treatment (excluding those who relapse within 6 months after the end of adjuvant therapy); 4. ECOG score of 0-1 points; 5. Adequate organ and bone marrow function, that is, meet the following criteria: (1) Routine blood examination criteria must meet (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): 1) Hemoglobin content (HB) >= 80g/L; 2) Neutrophil count (ANC) >= 1.5×10^9 /L; 3) Platelet count (PLT) > = 100×10^9 /L; (2) Biochemical examination must meet the following standards: 1) Serum total bilirubin (TBIL) 50%; 6. Women of non-childbearing potential, i.e., women who have been menopausal for at least 1 year or have undergone sterilization surgery (bilateral tubal ligation, double oophorectomy or hysterectomy); Patients of childbearing potential agree to use adequate contraception for 1 month before the start of the trial until 30 days after the end of the study: condoms, spermicidal condoms, foam, gel, contraceptive diaphragm, intrauterine device (IUD), contraceptives (administered orally or by injection); 7. The investigator judged that the patient could tolerate the treatment of ibergestim a.

Exclusion criteria

Exclusion criteria: 1. Clinical, electrocardiogram or other means diagnosed with acute congestive heart failure, cardiomyopathy or myocardial infarction; 2. People who are allergic to rubber; 3. Those who have received radiotherapy for bone lesions (except bone lesions, other lesions can be enrolled 4 weeks after receiving radiotherapy); 4. Received bone marrow transplantation or stem cell transplantation; 5. Women who are pregnant or breastfeeding; 6. Known human immunodeficiency virus (HIV) seropositive, or AIDS; 7. Active tuberculosis disease; or a recent history of contact with tuberculosis patients, unless the tuberculin test is negative; or Tuberculosis patients receiving treatment; or chest X-ray of suspected cases; 8. Patients who abuse alcohol or drugs, which affect their compliance with the study; 9. Known hypersensitivity to granulocyte colony-stimulating factors or drug excipients; 10. Received treatment with recombinant human granulocyte-stimulating factor within 6 weeks prior to inclusion; 11. Patients with concomitant other primary malignancies other than the diagnosis of colorectal cancer or pancreatic cancer, with the following exceptions: (1) Malignant tumors that have been in complete remission for at least 2 years before enrollment and do not require other treatment during the study; (2) Non-melanoma skin cancer or lentigo maligna that has been adequately treated and has no evidence of disease recurrence; (3) Carcinoma in situ that has been adequately treated and has no evidence of disease recurrence; 12. Use of other investigational drugs within 1 month before inclusion in this study; 13. The investigator believes that the patient has diseases or symptoms that make him unsuitable for participating in this study, and the investigational drug may harm the patient's health or affect the judgment of adverse events.

Design outcomes

Primary

MeasureTime frame
The incidence of ANC reduction >= grade 3 in the first cycle of chemotherapy;

Countries

China

Contacts

Public ContactYuan Ying

The second affiliated hospital of Zhejiang University school of medicine

yuanying1999@zju.edu.cn+86 571 87784818

Outcome results

None listed

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