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PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy | Clinical Trials | Clareo Health

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PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy

Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Jinyouli (PEGylated Recombinant Human Granulocyte Stimulating Factor, PEG-rhG-CSF) in Preventing Neutropenia After Chemotherapy in Elderly Patients With Small Cell Lung Cancer

NCT03776604•CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

Evaluation of the efficacy and safety of Jinyouli in preventing neutropenia in multiple chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter, open, one-arm study Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria, chemotherapy regimen: etoposide: 100 mg/m2, d1-3, carboplatin: AUC=5, d1, q21d, prophylactic use test 48 h after chemotherapy Drug PEG-rhG-CSF.

Eligibility

Age

70 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 70 years old, gender is not limited;
•Small cell lung cancer patients diagnosed by histopathology or cytology;
•ECOG = 0-1;
•The estimated survival period is more than 3 months;
•No obvious signs of hematological disease, defined as Hb≥90g/dL, WBC≥4.0×10\^9/L, ANC≥2×10\^9/L, PLT≥100×10\^9/L before enrollment. And no bleeding tendency;
•No obvious abnormalities were observed in the electrocardiogram examination;
•Liver function tests ALT, AST, TBIL indicators are within 2.5 times the upper limit of normal values. If due to liver metastasis, the above indicators should be within 5 times of the upper limit of normal. If LDH is elevated due to non-tumor causes, LDH should be ≤ 2.5 times the upper limit of normal; if LDH is elevated due to tumor, it can be enrolled;
•Renal function test BUN, UA within 1.5 times the upper limit of normal value, creatinine clearance rate\> 60ml / min;
•Subjects (or their legal representatives/guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.

Exclusion Criteria

•There are currently uncontrollable infections, body temperature ≥ 38.0 ° C;
•Patients with previous malignant tumors that have not been cured or have bone marrow metastasis;
•Patients with prophylactic antibiotics;
•Accepting other test drugs at the same time or participating in other clinical trials;
•Those who are allergic to this product or other genetically engineered E. coli-derived biological products;
•The patient has any myelodysplastic and other blood system diseases;
•Patients who have received hematopoietic stem cell transplantation or organ transplantation;
•The patient has a severe mental or neurological condition that affects informed consent and/or adverse reaction presentation or observation.

Locations (1)

Bejing Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 5, 2018

Primary Completion Date

December 1, 2019

Completion Date

February 1, 2020

Last Updated

December 19, 2018

Enrollment

ESTIMATED participants

Conditions

Small Cell Lung CancerPEG-rhG-CSF

Interventions

PEG-rhG-CSF

DRUG

Contacts

Jun Zhao, PhD

CONTACT

86-010-88196456 ohjerry@163.com

Hanxiao Chen

CONTACT

18810526948 Hanxiao0628@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy

Inclusion Criteria

Exclusion Criteria

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