Clinical trial NCT03776604: PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Small Cell Lung Cancer
PEG-rhG-CSF
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University Cancer Hospital & Institute
First posted: 2018-12-17
Enrollment: 61
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy.
Primary purpose: PREVENTION

Brief 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 criteria: 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.

Primary outcomes:
measure: The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
timeFrame: through first cycle of PEG-rhG-CSF,an average of 1 month
measure: The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
timeFrame: through second cycle of PEG-rhG-CSF,an average of 1 month
Secondary outcomes:
measure: The incidence of febrile neutropenia in cycles 1 and 2
timeFrame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
measure: The ANC recovery time in cycles 1 and 2
timeFrame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
measure: The incidence of infection
timeFrame: up to 30 days after the patient study completion
measure: The incidence of antibiotic use
timeFrame: up to 30 days after the patient study completion
measure: Incidence of chemotherapy dose adjustment due to neutropenia
timeFrame: through the study completion,an average of 3 months
measure: Chemotherapy delay time
timeFrame: through the study completion,an average of 3 months
measure: Incidence of chemotherapy delay caused by neutropenia
timeFrame: through the study completion,an average of 3 months
measure: The duration of febrile neutropenia in cycles 1 and 2
timeFrame: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
Other outcomes:
measure: Incidence and severity of adverse events
timeFrame: through the study completion,an average of 3 months
Locations:
city: Beijing
country: China
facility: Bejing Cancer Hospital
state: Beijing
Study officials:
References: