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Study on the Pharmacokinetics and Pharmacodynamics of Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor Injection in Patients with Tegafur Chemotherapy

Study on the Pharmacokinetics and Pharmacodynamics of Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor Injection in Patients with Tegafur Chemotherapy

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052849
Enrollment
Unknown
Registered
2021-11-06
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-08-23

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

Conditions

Malignancy

Interventions

Experimental group:Forty-eight hours after the first dose of tegafur, 6 mg/dose of PEG-rhG-CSF was injected subcutaneously

Sponsors

The Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years; 2. Patients with malignant tumor diagnosed by pathological examination and planned to receive Tegafur treatment; 3. ECOG score = 45 kg; 5. Normal bone marrow function, no hematological diseases. Routine blood test standards must be met (no blood transfusion and blood products, no correction with G-CSF and other hematopoietic stimulating factors within 14 days): Hb >= 90 g/L; ANC >= 1.5 x 10^9/L; PLT >= 80 x 10^9/L; 6. Biochemical examination should meet the following criteria; TBIL = 50 ml/min; 7. Patients with good compliance; 8. Can sign the informed consent; 9. Expected survival time >= 12 weeks.

Exclusion criteria

Exclusion criteria: 1. Uncontrollable infection; 2. Systemic antibiotic therapy within 72 hours before chemotherapy; 3. Bone marrow metastasis; 4. Allergic to this product or other genetically engineered E. coli derived biological products; 5. Pregnant or lactating women; women of childbearing age refused to accept contraceptive measures; 6. The researchers believe that they are not suitable for the group; 7. Unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled; 8. Suffering from mental illness or psychotropic drug abuse, can not cooperate; 9. Have participated in clinical trials within 4 weeks.

Design outcomes

Primary

MeasureTime frame
PEG-rhG-CSF concentration in peripheral blood;Hematology panel (focus on monitoring changes in ANC and WBC);Changes in CD34 +;

Secondary

MeasureTime frame
Adverse events;

Countries

China

Contacts

Public ContactLiu Yibing

The Fourth Hospital of Hebei Medical University

lyb.he@163.com+86 13831173220

Outcome results

None listed

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