The Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Camrelizumab Combined With Chemotherapy for Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma:A Phase II Clinical Study to Explore the Relationship Between Biomarkers and Efficacy
調査の概要
状態
条件
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
研究場所
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Beijing
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Beijing、Beijing、中国、100142
- Department of GI Oncology, Peking University 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
説明
Inclusion Criteria:
- Age: 18-75 years old, male or female;
- Esophageal squamous cell carcinoma was confirmed by pathology (except for cervical and Suprathoracic tumors that could not be operated);
- Patients with resectable esophageal squamous cell carcinoma with clinical stage T3-T4a or TxN + M0 (except T4b);
- ECOG PS score was 0-1;
- There was at least one measurable lesion (according to recist1.1) or unmeasurable lesion that could be evaluated, and the imaging diagnosis time was ≤ 21 days;
- The expected survival time was more than 3 months;
The function of the main organs was normal, and there were no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immunodeficiency diseases. The laboratory examination meets the following requirements:
- Hemoglobin (Hb) ≥ 90g / L;
- WBC ≥ 3.0 × 109/L; Neutrophil count (NEUT) ≥ 1.5 × 109/L;
- Platelet count (PLT) ≥ 100 × 109/L;
- Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50 ml / min (Cockcroft Gault formula);
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- The levels of AST and ALT were less than 2.5 times the upper limit of normal (ULN);
There was no active bleeding or thrombosis
- International normalized ratio INR ≤ 1.5 × ULN;
- Partial thromboplastin time APTT ≤ 1.5 × ULN;
- Prothrombin time Pt ≤ 1.5ULN;
- The patients with normal or mild to moderate abnormal lung function (VC% > 60%, FEV1 > 1.2L, FEV1% > 40%, DLco> 40%) could tolerate esophagectomy;
- The fertile female subjects were required to conduct blood pregnancy test within 72 hours before the first administration, and the result was negative, and voluntarily used appropriate contraceptive methods during the observation period and within 90 days after the last administration of the study drug; For men, surgical sterilization or consent to appropriate contraceptive methods during the observation period and within 90 days after the last administration of the study drug should be used.
- The subjects voluntarily joined the study and signed the informed consent form (ICF);
- The patients with good compliance were expected to follow up the efficacy and adverse events / reactions according to the protocol requirements.
Exclusion Criteria:
- Subjects who have received or are receiving additional chemotherapy, radiotherapy, targeted or immunotherapy;
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
- Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;
- Immunosuppressive drugs were used within 14 days before the first use of the study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids;
- Live attenuated vaccine was inoculated within 4 weeks before the first administration or during the study period;
- Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg);
- Subjects with uncontrollable clinical cardiac symptoms or diseases, such as (1) heart failure of NYHA II or above (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
- Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown origin > 38.5% occurred during the screening period / before the first administration;
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known;
- Pregnant or lactating women; The fertile subjects were unwilling or unable to take effective contraceptive measures;
- Other malignant tumors were found in the past or at the same time, but the cured basal cell carcinoma of skin, carcinoma in situ of cervix and carcinoma in situ of breast were excluded;
- Known to have allergic history to the drug components of this protocol;
- Other situations considered unsuitable by the researchers.
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:並列代入
- 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 |
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実験的:Camrelizumab+ Paclitaxel+ Cisplatin
The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1.
Esophageal cancer resection was performed after 3 cycles of medication (the researchers decided the follow-up treatment according to the postoperative pathological situation).
At the end of the treatment, the patients were followed up for safety and effectiveness.
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Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks. Paclitaxel: 80 mg / m2, intravenous drip for 180 minutes, D1, D8, repeated every 3 weeks. Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks. |
実験的:Camrelizumab+ Albumin bound paclitaxel+ Cisplatin
The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1.
Esophageal cancer resection was performed after 3 cycles of medication (the researchers decided the follow-up treatment according to the postoperative pathological situation).
At the end of the treatment, the patients were followed up for safety and effectiveness.
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Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks. Albumin bound paclitaxel: 130 mg / m2, intravenous drip for 30 minutes, D1, D8, repeated every 3 weeks. Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks. |
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 |
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biomarkers related to pCR
時間枠:9 weeks
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t has a good value in predicting the efficacy of immunotherapy, and is helpful for the accurate formulation of treatment plan and the accurate evaluation of prognosis of patients with esophageal cancer.
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9 weeks
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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 |
---|---|---|
Objective Response Rate
時間枠:9 weeks
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Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.
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9 weeks
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Disease Control Rate
時間枠:9 weeks
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Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated.
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9 weeks
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Disease free survival
時間枠:Time from randomization to patient's tumor progression or death
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The DFS will be defined as the time of patients alive without local recurrence or distant metastasis of disease from the date of the administration of treatment.
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Time from randomization to patient's tumor progression or death
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Overall Survival
時間枠:The time from the beginning of randomization to death due to any cause.
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OS is defined as the time from registration to death due to any cause, or censored at date last known alive.
Measured by the method of Kaplan and Meier
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The time from the beginning of randomization to death due to any cause.
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Safety
時間枠:from first treatment to 90 days after esophagectomy
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Adverse events
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from first treatment to 90 days after esophagectomy
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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
- MA-EC-II-005
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。
Camrelizumab+ Paclitaxel+ Cisplatinの臨床試験
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Ajou University School of Medicine積極的、募集していない
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Medtronic Endovascular完了
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Conor Medsystems終了しました
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Hemoteq AG完了冠動脈疾患 | 冠動脈硬化症 | 冠動脈アテローム性動脈硬化症 | 冠動脈再狭窄ドイツ, フランス
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Fondazione Evidence per Attività e Ricerche Cardiovascolari...わからない
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EBG MedAustron GmbHLandesklinkum Wiener Neustadt募集
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Xijing Hospital積極的、募集していない