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

NCT ID: NCT03206684

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2018-09-30

Brief 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

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEG-rhG-CSF

PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，with patients' weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight \<45kg were given 3mg once per chemotherapy cycle.

Group Type: EXPERIMENTAL

PEG-rhG-CSF

Intervention Type: DRUG

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 daily 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.

Group Type: ACTIVE_COMPARATOR

rhG-CSF

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

PEG-rhG-CSF single-dose administered; rhG-CSF daily administered

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Mei Shi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mei Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Locations

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Mei Shi, MD

Role: CONTACT

Shimei82@gmail.com

+86-29-84775425

Facility Contacts

Mei Shi, MD

Role: primary

Shimei82@gmail.com

+86-029-84775425

Other Identifiers

CSPC-JYL-CC-01

Identifier Type: -

Identifier Source: org_study_id