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.