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

CSPC Pharmaceutical Group

Status: Unknown

Conditions: PEG-rhG-CSF; Small Cell Lung Cancer

Treatments: Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03776604

CSPC-JYL-SCLC-01

Details and patient eligibility

About

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.

Enrollment: 61 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

PEG-rhG-CSF

Experimental group

Description:

Jin Youli(PEG-rhG-CSF): The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were \<45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle. Dosing time: 48 h after chemotherapy.

Treatment:

Drug: PEG-rhG-CSF