Overview

Study on the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia During Concurrent Chemoradiotherapy of Cervical Cancer

Status:
Active, not recruiting
Trial end date:
2021-05-26
Target enrollment:
0
Participant gender:
Female
Summary
This randomized controlled prospective study aims to explore the efficacy and safety of using (PEGylated Recombinant Human Granulocyte Stimulating Factor) PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. To find out the best time to use PEG-rhG CSF, and to explore investigate the effect of PEG-rhG-CSF on long-term bone marrow function in the process of concurrent chemoradiotherapy, and finally to explore the clinical feasibility of using PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of TP regimen for cervical cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chongqing University Cancer Hospital
Criteria
Inclusion Criteria:

1)18-70 years old; 2)Patients with cervical cancer who have not undergone surgery for
initial treatment, the international union of gynecology and obstetrics (FIGO) stage
IIb-IIIb; Squamous cell carcinoma diagnosed by histopathology.

3)The expected survival time was more than 8 months; the Eastern Cooperative Oncology Group
(ECOG) performance status score≤1; 4)Bone marrow hematopoietic function is normal before
treatment (ANC≥1.8×109/L, PLT≥100×109/L, Hb≥90g/L, WBC≥4.0×109/L); 5)No obvious abnormality
in the ECG examination, and no obvious cardiac dysfunction; 6)All patients must agree to
take effective contraceptive measures during the study period and within 6 months after
stopping treatment, and women of childbearing age must have a negative urine pregnancy test
prior to treatment administration; 7)The subjects voluntarily participate in this clinical
trial and sign an informed consent form.

Exclusion Criteria:

1)Those who refuse to accept PEG-rh-G-CSF; 2) Currently conducting clinical trials of other
drugs; 3) Uncontrolled infection before treatment, body temperature ≥ 38℃; 4)Chronic
diseases of the heart, kidney, liver or other important organs; 5) Patients with severe
uncontrolled diabetes; (6) Pregnant or lactating female patients; 7)Persons with allergic
diseases or allergic constitution, or allergic to this product or other biological products
derived from genetically engineered E. coli; 8) Suspected or confirmed drug, substance or
alcohol abuse; 9) Severe mental or neurological disorders that affect informed consent
and/or adverse reaction presentation or observation; 10)HIV-positive people; 11)Patients
requiring radiation therapy for the retroperitoneal or inguinal region.