Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
A Prospective Study of Intraperitoneal and Intravenous Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前:Qun Zhao, Professor
- 電話番号:13930162111
- メール:Zhaoqun516@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:
- None previous chemotherapy, radiotherapy and other antitumor therapy;
- Age:18 to 70 years old;
- Man or female (except pregnant and lactating women);
- Confirmed to gastric adenocarcinoma and HER2-negative;
- Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
Blood cell count has to meet the following certeria:
WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
Liver/kidney function has to meet the following certeria:
ALT and AST≤2.5×ULN TBIL<1.5×ULN; Serum creatinine ≤1.5×ULN;
- Left ventricular ejection fraction (LVEF) ≥50%;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Participants were willing to join in this study, good adherence and written informed consent.
Exclusion Criteria:
- Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
- The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
- Patients with other malignant tumors within 5 years;
- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study;
- Distant metastasis;
- It has serious or uncontrolled medical diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Patients with severe or uncontrollable mental illness;
- It have serious harm to the patient's safety or affect the patients who have completed the research.
- The researchers think inappropriate.
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:なし
- 介入モデル:単一グループの割り当て
- 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:Experimental
Camrelizumab: 200mg,iv,30min, q3w, 4 cycles. Nab-Paclitaxel: intraperitoneal nab-paclitaxel 80 mg/m2 and intravenous nab-paclitaxel 180 mg/m2 on days 1, q3w, 4 cycles. S-1:According to the body surface area, BSA <1.25m2,40mg bid; 1.25m2≤BSA≤1.5m2,50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week, q3w, 4 cycles. For patients who were operable, the original regimen was continued for 4 cycles of adjuvant treatment after operation, followed by maintenance of carrelizumab monotherapy to 1 year. Inoperable patients were selected for follow-up treatment according to guidelines recommended by the investigator. |
Camrelizumab+S-1+Intraperitoneal nab-paclitaxel and intravenous nab-paclitaxel
|
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 |
---|---|---|
R0切除率
時間枠:手術後3週間以内
|
顕微鏡で見ても残留物はありませんでした
|
手術後3週間以内
|
Conversion to negative rate
時間枠:within 3 weeks after surgery
|
Exfoliative cytology positive gastric cancer conversion to negative rate
|
within 3 weeks after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Overall survival (OS)
時間枠:3years
|
Baseline to measured date of death from any cause
|
3years
|
Progression free survival (PFS)
時間枠:3years
|
Baseline to measured date of progression or death from any cause
|
3years
|
Objective response rate (ORR)
時間枠:tumor assessment every 6 weeks since the treatment began,up to 3years
|
Baseline to measured stable disease
|
tumor assessment every 6 weeks since the treatment began,up to 3years
|
Disease control rate (DCR)
時間枠:tumor assessment every 6 weeks since the treatment began,up to 3years
|
Baseline to measured progressive disease
|
tumor assessment every 6 weeks since the treatment began,up to 3years
|
Tumor regression grade (TRG)
時間枠:within 3 weeks after surgery
|
TRG included four grades: Grade 0-3
|
within 3 weeks after surgery
|
Adverse events
時間枠:3 years
|
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
The number of Participants with adverse events will be recorded at each treatment visit.
|
3 years
|
協力者と研究者
スポンサー
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
追加の関連 MeSH 用語
その他の研究ID番号
- HRCG-001
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
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。
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-
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