The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study
調査の概要
状態
条件
詳細な説明
Establish a clinical database for the advanced gastric cancer patients treated with first-line combined chemotherapy in Tongji hospital.
1.1.Data including age, gender, smoking state, karnofsky performance score(KPS), disease history, clinical stage, primary tumor site, metastasis site, surgery, first-line chemotherapy, therapy after failure of first-line treatment, radiotherapy, toxicity, survival time, the time of free of progress, response were collected.
1.2.The peripheral blood samples were collected for further biomarker reserch.
- Kaplan-Meier and Cox model will be used to analyze the overall survival(OS) and progression-free survival(PFS) of advanced gastric cancer.
- Extract Deoxyribonucleic acid(DNA) from the the peripheral blood and research biomarkers related to the first-line combined chemotherapy for AGC.
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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Hubei
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Wuhan、Hubei、中国、430030
- 募集
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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主任研究者:
- Xianglin Yuan, MD,PHD
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コンタクト:
- Xianglin Yuan, MD,PHD
- 電話番号:1 13667241722
- メール:yxl@medmail.com.cn
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コンタクト:
- Suxian Wei, Master
- 電話番号:1 15927421058
- メール:wsxattj@126.com
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副調査官:
- Suxian Wei, MD
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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:
- Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
- Unresectable locally advanced, or recurrent, or metastasis disease;
- Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed.
- Life expectancy of at least 3 months;
- ECOG score 0-2;
- Voluntarily signed the informed consent.
Exclusion criteria:
- Previously treated with first-line chemotherapy;
- First-line chemotherapy with single drug.
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
コホートと介入
グループ/コホート |
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Combined chemotherapy
AGC patients treated with first-line combined 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 |
時間枠 |
---|---|
Overall survival(OS) . overall survival Overall survival(OS)
時間枠:From date of enrollment until the date of death from any cause, assessed up to 60 months
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From date of enrollment until the date of death from any cause, assessed up to 60 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Progression-free survival(PFS)
時間枠:From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
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From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
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Objective response rate(ORR)
時間枠:The sum of complete remission (CR) rate and partial remission (PR) rate. Response will be measured through first-line treatment completion, up to 1 year
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The sum of complete remission (CR) rate and partial remission (PR) rate. Response will be measured through first-line treatment completion, up to 1 year
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Disease control rate(DCR)
時間枠:The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year
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The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
時間枠:Through first-line treatment completion,up to 24 weeks.
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Through first-line treatment completion,up to 24 weeks.
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協力者と研究者
捜査官
- 主任研究者:Xianglin Yuan, MD,PHD、Tongji Hospital
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
胃癌の臨床試験
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