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

Efficacy and Safety of PEGylated Recombinant Human Granulocyte Stimulating Factor in the Prevention of Neutropenia During Concurrent Chemoradiotherapy for Cervical Cancer

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.

Study design: In this prospective, single-center, randomized controlled study, patients with locally advanced cervical cancer are randomly divided into two groups. Patients in the experimental group will receive PEG-rhG-CSF 6mg prevention during concurrent chemoradiotherapy, whereas the control group do not use PEG-rhG-CSF for prevention. When the patient's ANC is less than 1✕109/L, 5μg/kg rhG-CSF will be given for treatment until the ANC returned to 2✕109/L.

Case selection: patients with IIb-IIIb cervical cancer, squamous cell carcinoma confirmed by histopathology, and three-week regimen of paclitaxel and carboplatin with Concurrent Radiotherapy.

Primary end point: incidence and duration of grade 3/4 neutropenia in patients. Secondary endpoints: 1) Incidence of febrile neutropenia (FN); 2) the rate of postponement of the course of radiotherapy, reduction in chemotherapy dose and postponement of the course of chemotherapy; 3) Changes of bone marrow function in patients 3 months and 6 months after radiotherapy.

Safety assessment: laboratory safety testing, including platelet count and hemoglobin. Evaluation of adverse events: infection, neutropenic fever, bone pain, etc.

Inclusion Criteria:

• 18-70 years old;
• 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.
• The expected survival time was more than 8 months; the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;
• 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);
• No obvious abnormality in the ECG examination, and no obvious cardiac dysfunction;
• 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;
• The subjects voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

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