Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies
A Multicenter, Randomized Controlled, Open Clinical Study of the Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemotherapy in Patients With Gynecological Malignancies
This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy.
Patients are randomized into study group and control group. All patients receive PTX+platinum chemotherapy of 3 weeks. In study group, patients accept PEG-rhG-CSF 24-48 hours from the chemotherapy. While the control group patients are only observed closely. Patient receive three courses of treatment.
The primary end is the incidence of 3/4 level neutropenia in three courses of chemotherapy.
The secondary ends include: the incidences and duration of neutropenia in every course of chemotherapy, the incidences of FN in three courses and every course of chemotherapy, the incidences of infection in three courses and every course of chemotherapy, the delay time of the next cycle of chemotherapy due to FN or infection, the RDI of the second and third cycles of chemotherapy, adverse events related to G-CSF, quality of life, cost of medicine and admitting.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lingfang Xia, M.D.
- 電話番号：13774211977
- メール：nightxlf@163.com
研究連絡先のバックアップ
- 名前：Xiaohua Wu, MD&PHD
- 電話番号：+862164175590
- メール：alizheng@126.com
研究場所
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-
Shanghai
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Shanghai、Shanghai、中国
- No. 270, Dongan Road, Xuhui District, Shanghai, China
-
コンタクト：
- Xiaohua Wu
- 電話番号：+862164175590
- メール：alizheng@126.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Ages 18-70
- Weight ≥45 kg
- ≤2 lines chemotherapy or postoperative adjuvant chemotherapy patients with cervical cancer, ovarian cancer and endometrial cancer
- Receive paclitaxel combined with platinum three weeks per cycle of chemotherapy
- With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Expected survival time of > 3 months
Main organ functions meet the following criteria:
- Hb≥75g/L; WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥80×109/L;
- APTT-ULN≤10s; PT-ULN≤3s; TT-ULN≤3s;
- ALT≤2.5×ULN; AST≤2.5×ULN; TBIL≤2.5×ULN;
- BUN≤1.5×ULN; Cr≤1.5×ULN; UA≤1.5×ULN；Creatinine clearance≥40mL/min;
- without obvious cardiac dysfunction
- Provided consent for participation
Exclusion Criteria:
- With uncontrollable infections or receive systemic antibiotics within 72 hours prior to chemotherapy
- Pregnant or lactating women
- Received bone marrow or hematopoietic stem cell transplantation within the past 3 months
- Concurrent chemoradiotherapy
- Presence of hematological disorders: systemic lupus erythematosus, sjogren's syndrome, rheumatic autoimmune disease, mixed and hoof tissue disease, autoimmune hemolytic anemia, leukopenia , chronic granulocyte leukemia, bone marrow dysplasia syndrome, aplastic anemia, congenital and idiopathic neutropenia, myelodysplastic syndrome, cyclic neutropenia, primary and secondary thrombocytopenic purpura, etc
- Presence of risk of thrombus or high risk of clotting
- Presence of psychosis, neurological disease or brain metastases from tumors
- Presence of uncontrollable complicated disease including symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, active peptic ulcer, or hemorrhagic disease
- Presence of uncontrollable infectious diseases, active viral hepatitis, tuberculosis, HIV
- Allergic to recombinant human granulocyte stimulating factor or other biological products of E. coli origin
- Received clinical trials within 1 month prior to enrollment
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：PEG-rhG-CSF prevention
Mecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle,
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24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle
他の名前：
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介入なし：non-prevention
Only close monitoring after chemotherapy
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of third/fourth level neutropenia
時間枠：three months
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Incidence of third/fourth level neutropenia during three cycles chemotherapy
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three months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of febrile neutropenia
時間枠：three months
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Incidence of febrile neutropenia during every cycle chemotherapy
|
three months
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The duration time of third/fourth level neutropenia
時間枠：three months
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The duration time of third/fourth level neutropenia during three cycles chemotherapy
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three months
|
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Incidence of infection
時間枠：three months
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Incidence of third/fourth level neutropenia during three cycles chemotherapy
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three months
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delay time of chemotherapy
時間枠：three months
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The delay time of the next cycle of chemotherapy due to FN or infection
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three months
|
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RDI of chemotherapy
時間枠：three months
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Relative dose intensity of the second and third chemotherapy
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three months
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Adverse events
時間枠：three months
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Incidence of adverse events related to granulocyte colony stimulating factor according to common Terminology Criteria for Adverse Events (CTCAE) v5.0
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three months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Xiaohua Wu, MD&PHD、director of gynecologic oncology
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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