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A prospective, open, single arm study for the efficacy and safty analysis of pegfilgrastim in preventing neutropenia in patients with head and neck cancer after concurrent chemoradiotherapy

A prospective, open, single arm study for the efficacy and safty analysis of pegfilgrastim in preventing neutropenia in patients with head and neck cancer after concurrent chemoradiotherapy

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019807
Enrollment
Unknown
Registered
2018-11-30
Start date
2018-06-28
Completion date
Unknown
Last updated
2018-12-04

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

Conditions

head and neck cancer

Interventions

Case series:48h after chemotherapy, PEG-rhG-CSF, subcutaneous injection, once per cycle

Sponsors

General Hospital of Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old; 2. Patients with head and neck cancer diagnosed by histopathology; 3. Patients requiring multi-cycle concurrent chemoradiotherapy; 4. The patient has no serious complications; 5. KPS =70; 6. There were no obvious signs of hematological diseases. Before enrollment, ANC=1.5×10^9/L, platelet count=80×10^9/L, Hb=75g/L, and no bleeding tendency; 7. The patient signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are currently uncontrolled infections or systemic antibiotics within 72 hours of receiving chemotherapy; 2. Any abnormal bone marrow hyperplasia and other hematopoietic functions; 3. Patients who have received bone marrow or hematopoietic stem cell transplantation within the past 3 months; 4. Patients with previous malignant tumors that have not been cured, or have brain metastases; 5. TBIL, ALT, AST were >2.5 times the upper limit of normal; if due to liver metastasis, the above indicators >5 times the upper limit of normal; 6. Renal function test: Cr > 1.5 times the upper limit of normal; 7. Anyone who is allergic to this product or other genetically engineered E. coli source; 8. Suffering from mental or systemic diseases, unable to cooperate; 9. Researchers believe that patients who are not suitable for the trial.

Design outcomes

Primary

MeasureTime frame
Dynamic Changes of Neutrophil Count Supported by Jin Youli;

Secondary

MeasureTime frame
Incidence of neutropenic fever in each cycle of chemotherapy;Incidence of iii / iv neutropenia in each cycle of chemotherapy supported by JinYouLi;Drug dose adjustment ratio caused by neutropenia in each cycle of chemotherapy;Incidence of delayed chemotherapy caused by neutropenia in each cycle of chemotherapy;Hospitalization rate of patients supported by Jin You Li;antibiotic utilization rate;

Countries

China

Contacts

Public ContactFang Liu

General Hospital of Chinese People's Liberation Army

liufangfsq@163.com+86 13520469875

Outcome results

None listed

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