To Evaluate the Efficacy and Safety of PEG-rhG-CSF（Jinyouli®） in Reducing Neutropenia in Patients With Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

A Prospective, Open, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF in Reducing Neutropenia in Patients With Cervical Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03206684
• Other study ID #: CSPC-JYL-CC-01
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 30, 2017
• Last updated: August 25, 2017
• Start date: August 2017
• Est. completion date: September 2018

Study information

• Verified date: August 2017
• Source: Fourth Military Medical University
• Contact: Mei Shi, MD
• Phone: +86-29-84775425
• Email: Shimei82[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection) in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age =18, =70 years old;

2. Cervical cancer patients diagnosed by histopathology;

3. Need to receive multi-cycle radical concurrent radiochemotherapy;

4. FN risk > 20% if rhG-CSF was not accepted; High risk factors associated with FN and planed to use the same protocol in subsequent cycles(docetaxel+cisplatin regimen);

5. Performance status score(KPS)=70;

6. No obvious blood system disease,absolute neutrophil count(ANC)= 1.5×10^9/L, platelet count=80×10^9 /L, hemoglobin(Hb)=75 g/L, and no bleeding tendency;

7. The patient signs the informed consent.

Exclusion Criteria:

1. With infection difficult to control, or received system antibiotic treatment within 72 h before chemotherapy;

2. Any bone marrow abnormalities and other hematopoietic ;

3. Had received bone marrow or hematopoietic stem cell transplantation within 3 months;

4. with other malignancies not cure, or with brain metastases;

5. Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all =2.5 times normal upper limit.

6. Renal function tests: serum creatinine (Cr)> 1.5 times normal upper limit;

7. Allergic to the drugs or other genetic engineering biological products from Escherichia coli;

8. Suffering from mental or neurological disorders;

9. Investigator think it is not suitable for recruiting.

Related Conditions & MeSH terms

• Cervical Cancer
• Neutropenia
• Uterine Cervical Neoplasms

Intervention

Drug:
• PEG-rhG-CSF
PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy,weight = 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle.
• rhG-CSF
rhG-CSF was administered subcutaneously 48h after chemotherapy,weight=45kg were given 300µg/d, weight<45kg were given 150µg/d,continuous injection for 3-5 days until the absolute neutrophils count=2×10^9/L.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of III/IV neutropenia	The incidence of III/IV neutropenia in each chemotherapy cycle	3 months
Secondary	Incidence of FN	Incidence of febrile neutropenia (FN) in each chemotherapy cycle	3 months
Secondary	Proportion of chemotherapy dose adjustment	Proportion of chemotherapy dose adjustment due to neutropenia	3 months