- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03776604
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
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100142
- 모병
- Bejing Cancer Hospital
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연락하다:
- Jun Zhao, PhD
- 전화번호: 86-010-88196456
- 이메일: ohjerry@163.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: PEG-rhG-CSF
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. |
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. 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
기간: through first cycle of PEG-rhG-CSF,an average of 1 month
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The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
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through first cycle of PEG-rhG-CSF,an average of 1 month
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The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
기간: through second cycle of PEG-rhG-CSF,an average of 1 month
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The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
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through second cycle of PEG-rhG-CSF,an average of 1 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The incidence of febrile neutropenia in cycles 1 and 2
기간: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
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Febrile neutropenia (FN) is defined as oral temperature >38.3 ° C (underarm temperature >38.1 ° C) or continuous measurement of oral temperature >38 ° C (underarm temperature >37.8 ° C) in 2 h, and ANC <0.5×10^9/L, or expected to be <0.5×10^9/L
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through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
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The ANC recovery time in cycles 1 and 2
기간: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
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Defined as the patients who appear ANC<2.0×10^9/L,from the first day of chemotherapy, to the time of ANC≥ 2.0×10^9/L, take the median.
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through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
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The incidence of infection
기간: up to 30 days after the patient study completion
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up to 30 days after the patient study completion
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The incidence of antibiotic use
기간: up to 30 days after the patient study completion
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up to 30 days after the patient study completion
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Incidence of chemotherapy dose adjustment due to neutropenia
기간: through the study completion,an average of 3 months
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through the study completion,an average of 3 months
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Chemotherapy delay time
기간: through the study completion,an average of 3 months
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through the study completion,an average of 3 months
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Incidence of chemotherapy delay caused by neutropenia
기간: through the study completion,an average of 3 months
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through the study completion,an average of 3 months
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The duration of febrile neutropenia in cycles 1 and 2
기간: through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
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through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence and severity of adverse events
기간: through the study completion,an average of 3 months
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All adverse events will be recorded from the time of signing the informed consent form to 30 days after the last dose.
Adverse events 30 days after the last dose, only those adverse events associated with the study drug were recorded.
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through the study completion,an average of 3 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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