Apatinib in Advanced Non-squamous,NSCLC
Prospective, Multicenter, Non-intervention Clinical Trial of Apatinib in the Treatment of Advanced Non-squamous,Non-small Cell Lung Cancer
調査の概要
詳細な説明
This is a multi-center, non-interventional clinical study. The number of patients that planned to be recruited is: from May 2017 to April 2019, the actual number of cases recruited into this study.
If the clinicians thought the patient is suitable to take apatinib treatment, and give the patient apatinib treatment, the patient can be recruited into this study. Clinicians chose the initial dose of apatinib according to the patient's physical condition. Besides the clinicians adjusted the dose according to the patient's tolerance during the medication. The dosage was demanded not higher than 750 milligram (mg) per day. The patients received apatinib continuously, 28 days for a period, until intolerance, no longer getting benefits or patient wanted stop.
During the course of the study, the researchers will not intervene the treatment of the patients, but only record the efficacy and adverse reactions.
Main evaluation criteria: PFS Secondary evaluation criteria: OS,DCR and ORR (according to RECIST1.1). Main safety indicators:AE, SAE (according to NCI CTCAE V4.0) and QOL scores (Quality of Life Questionnaire-lung cancer).
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Beijing
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Beijing、Beijing、中国、100142
- 募集
- Beijing Cancer Hospital
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age: ≥ 18 years old;
- Histologically or cytologically confirmed, locally advanced or stage IV non-squamous, non-small cell lung cancer;
- Regardless of the past anti-tumor treatments (no limited to the number of past treatment lines), the doctors believe that apatinib can bring benefits to patients;
- The patient is voluntarily to join the study, and signed informed consent, good compliance, with follow-up.
Exclusion Criteria:
If any of the following criteria is met, the subject shall be excluded:
- Squamous cell carcinoma and/or small cell lung cancer patients;
- There are contraindications to apatinib (active bleeding, thrombosis, ulcers, intestinal perforation, intestinal obstruction, uncontrollable hypertension, grade III-IV cardiac insufficiency, major surgery within 30 days, severe liver and kidney dysfunction, etc.);
- Allergic to apatinib and / or its excipients;
- Pregnant or lactating women;
- According to the researcher's judgment, there are other situations that may increase the risk associated with participating in this study or the drug, which may lead to patients not being eligible for enrollment in the study.
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
- 観測モデル:コホート
- 時間の展望:見込みのある
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 |
---|---|---|
PFS (Progression-Free survival)
時間枠:From the date Into this study (signed ICF) to tumor progression or death for any reason,whichever came first, assessed up to 36 months
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From the date Into this study (signed ICF) to tumor progression or death for any reason.
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From the date Into this study (signed ICF) to tumor progression or death for any reason,whichever came first, assessed up to 36 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 |
---|---|---|
OS (Overall survival)
時間枠:From the date Into this study (signed ICF) to death for any reason,assessed up to 60 months.
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From the date Into this study (signed ICF) to death for any reason.
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From the date Into this study (signed ICF) to death for any reason,assessed up to 60 months.
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DCR (Disease control rate)
時間枠:From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months.
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The rate of CR, PR plus SD
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From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months.
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ORR(目標制御率)
時間枠:この研究の開始日(ICFに署名)から腫瘍の進行まで、最大36か月まで評価されました。
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CRとPRの割合
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この研究の開始日(ICFに署名)から腫瘍の進行まで、最大36か月まで評価されました。
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
AE (Adverse events)
時間枠:From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death,whichever came first, assessed up to 36 months.
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AE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0).
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From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death,whichever came first, assessed up to 36 months.
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SAE (Severe adverse events)
時間枠:From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death,whichever came first, assessed up to 36 months.
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SAE is classified and graded by Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0).
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From the date Into this study (signed ICF) to 30 days after tumor progression, 30days after exit this research, or death,whichever came first, assessed up to 36 months.
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QOL scores
時間枠:From the date Into this study (signed ICF) to tumor progression, exit this research, or death,whichever came first, assessed up to 36 months.
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Quality of life scores
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From the date Into this study (signed ICF) to tumor progression, exit this research, or death,whichever came first, assessed up to 36 months.
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
- Didkowska J, Wojciechowska U, Manczuk M, Lobaszewski J. Lung cancer epidemiology: contemporary and future challenges worldwide. Ann Transl Med. 2016 Apr;4(8):150. doi: 10.21037/atm.2016.03.11.
- Hall RD, Le TM, Haggstrom DE, Gentzler RD. Angiogenesis inhibition as a therapeutic strategy in non-small cell lung cancer (NSCLC). Transl Lung Cancer Res. 2015 Oct;4(5):515-23. doi: 10.3978/j.issn.2218-6751.2015.06.09.
- Zhang H. Apatinib for molecular targeted therapy in tumor. Drug Des Devel Ther. 2015 Nov 13;9:6075-81. doi: 10.2147/DDDT.S97235. eCollection 2015.
- Fontanella C, Ongaro E, Bolzonello S, Guardascione M, Fasola G, Aprile G. Clinical advances in the development of novel VEGFR2 inhibitors. Ann Transl Med. 2014 Dec;2(12):123. doi: 10.3978/j.issn.2305-5839.2014.08.14.
- Zhang L, Shi M, Huang C et al. A phase II, multicenter, placebo-controlled trial of apatinib in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) after two previous treatment regimens. J Clin Oncol 2012; 30: Abst 7548.
- Mi YJ, Liang YJ, Huang HB, Zhao HY, Wu CP, Wang F, Tao LY, Zhang CZ, Dai CL, Tiwari AK, Ma XX, To KK, Ambudkar SV, Chen ZS, Fu LW. Apatinib (YN968D1) reverses multidrug resistance by inhibiting the efflux function of multiple ATP-binding cassette transporters. Cancer Res. 2010 Oct 15;70(20):7981-91. doi: 10.1158/0008-5472.CAN-10-0111. Epub 2010 Sep 28.
- Ding L, Li QJ, You KY, Jiang ZM, Yao HR. The Use of Apatinib in Treating Nonsmall-Cell Lung Cancer: Case Report and Review of Literature. Medicine (Baltimore). 2016 May;95(20):e3598. doi: 10.1097/MD.0000000000003598.
- Fan M, Zhang J, Wang Z, Wang B, Zhang Q, Zheng C, Li T, Ni C, Wu Z, Shao Z, Hu X. Phosphorylated VEGFR2 and hypertension: potential biomarkers to indicate VEGF-dependency of advanced breast cancer in anti-angiogenic therapy. Breast Cancer Res Treat. 2014 Jan;143(1):141-51. doi: 10.1007/s10549-013-2793-6. Epub 2013 Dec 1.
研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- APTN-NIS-NSCLC-BCH
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?
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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非扁平上皮非小細胞肺がんの臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ