Cervical cancer
Conditions
Interventions
Case series:Thiopifegerstine injection
Sponsors
The Ninth Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. The pathological diagnosis in installment for IIB - IV (FIGO, 2018 edition) of cervical squamous carcinoma; 3. ECOG score 0-2; 4. Expected survival >=12 weeks; 5. Patients who are willing to accept postoperative concurrent chemoradiotherapy and platinum chemotherapy regimen; 6. No serious dysfunction of heart, lung, liver, kidney or other important organs; No jaundice and digestive tract obstruction; No acute infection; 7. Hematological examination shall meet the following standards: (1) White blood cell count >=3x10^9/L; (2) Neutrophils >=1.5x10^9/L; (3) Platelet count >=100x10^9/L; (4) Hemoglobin >=100g/L 8. Biochemical examination shall meet the following standards: (1) AST and ALT 60ml/min (Cockcroft-Gault formula); 9. Women of childbearing age must have a pregnancy test (serum) that is negative within 7 days of enrolment and be willing to use an appropriate method of contraception during the test and 8 weeks after the last dose of the test drug; For men, surgical sterilization or consent to the use of an appropriate method of contraception during the trial period and 8 weeks after the last dose of the experimental drug; 10. The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Distant metastasis of the lesion; 2. Allergic to this product or other biological products derived from genetically engineered E. coli; 3. Patients were treated with PEG recombinant human granulocyte stimulating factor (PEG-RHG-CSF), recombinant human granulocyte colony stimulating factor (RHG-CSF) and this product within 1 month before enrollment; 4. Have a history of other malignant tumors; 5. Known or suspected allergy to chemotherapy drugs platinum and albumin paclitaxel or possible allergy; 6. Accompanied by serious heart, liver and kidney diseases;Neurological and mental diseases;Or uncontrolled clinical symptoms or disease of the heart; 7. Severe concomitant diseases shall be judged by the researcher to affect the safety and compliance of the study; 8. Have active infection or have unexplained fever of > 38.5 degrees during screening or before the first administration (subject can be enrolled with fever caused by tumor according to the determination of the researcher); 9. Use of systemic antibiotics within 1 week prior to the start of the study; 10.4 weeks of systemic chemotherapy; 11. Participated in other drug clinical trials within 4 weeks before enrollment; 12. Have a history of substance abuse or addiction; 13. Pregnant or lactating women; 14. Any bone marrow dysplasia and other hematopoietic abnormalities 15. Failure to cooperate with follow-up visits or poor compliance; 16. The researcher believes that those who are not suitable for inclusion. The lack of data in the screening period affects the judgment of efficacy and safety; 1. Due to the toxicity of the treatment, severe treatment complications occurred, and the patient could not tolerate the treatment; 2. The drug is not administered according to the prescribed dose, method and course of treatment, which affects the judgment of drug efficacy; 3. Disease progression during treatment; 4. Subject lost to follow-up; 5. Subject is pregnant; 6. Death of the subject; 7. Withdrawal from the study requested by the subject or his legal representative; 8. The continuation of research for medical or ethical reasons; 9. Serious violation of the pilot protocol (including serious violation of study inclusion conditions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3-4 ANC reduction;Chemoradiation III / IV degree during neutrophils (ANC) reduce the incidence of disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of neutropenic fever (FN) in each cycle;The incidence of delayed chemotherapy due to neutropenia in each cycle;The proportion of chemotherapeutic drug dose adjustments due to neutropenia in each cycle;Antibiotic utilization rate in each cycle;Incidence of neutropenic fever (FN) in each cycle;The incidence of delayed chemotherapy due to neutropenia in each cycle;The proportion of chemotherapeutic drug dose adjustments due to neutropenia in each cycle;Antibiotic utilization rate in each cycle;Other Adverse events (AE) and severe adverse events (SAE); | — |
Contacts
Public ContactFu Zhichao
The Ninth Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army
Outcome results
None listed