Anlotinib Combined With Sintilimab as Second-line Treatment or Beyond in Patients With Small Cell Lung Cancer
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究連絡先
- 名前:Tong Zhou
- 電話番号:+86-519-69807727
- メール:zhoutong2930@163.com
研究場所
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Jiangsu
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Changzhou、Jiangsu、中国、213000
- 募集
- Changzhou Cancer Hospital of Soochow University
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コンタクト:
- Tong Zhou
- 電話番号:15861153525
- メール:zhoutong2930@163.com
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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:
- Patients should participate in the study voluntarily and sign informed consent;
- Male or female aged over 18 years;
- Histological documentation of small cell lung cancer
- Advanced small cell lung cancer who failed first-line chemotherapy ,at least one measurable lesion (by RECIST1.1)
- ECOG PS:0-2,.
- Life expectancy of more than 3 months
The laboratory results at the screening point must meet the following requirements:
(a) Blood routine: the absolute neutrophile count (ANC) shoud be more than 1.0 x 109/L, the platelet count (PLT) should be more than 100 x 109/L, the hemoglobin (HGB) should be more than 90g/L (no blood transfusion or erythropoietin dependence within 7 days);
B) Liver function: total bilirubin (TBIL) should be less than or equal to 1.5 times of the upper limit of normal (ULN); avoid the subjects with liver metastasis, who had the levels of ALT and AST less than the 2.5 times of ULN; and the levels of ALT and AST in subjects with liver metastasis should less than the 5 times of ULN;
C) Renal function: the level of serum creatinine (Cr) should less than 1.5 times of ULN or the clearance ratio of Cr should higher than 60 mL/min
(Cockcroft-Gault formula) and the test results of urine routine showed the urine protein (UPRO) content should less than 2 + or should less than 1 g at the 24-hour urinary protein quantification;
- For female subjects with reproductive age, the urine or serum pregnancy test should be negative within three days before receiving the first administration of the researched drug (the first cycle, first day). If the urine pregnatncy test is not enough to confirm the negative results, then the blood pregnancy test is required.
- The compliance of the research programs is expected to be good.
Exclusion Criteria:
- Patients who have been used anlotinib or Sintilimab;
- Other malignant tumors (except clinically cured cervical carcinoma in situ, basal cell or squamous cell skin cancer and papillary thyroid cancer) that were concurrently diagnosed or have occurred within 5 years.
- The patients who had received chemotherapy, radiotherapy or other experimental anticancer therapy within 4 weeks before treatment; those who had received local radiotherapy in the past could be included in this research, if the following conditions were meet: radiotherapy was performed more than 4 weeks before the beginning of this study (brain radiotherapy was performed more than 2 weeks), and the target lesions selected in this study were not in the radiotherapy area, or the target lesions were in the radiotherapy area, but the progress was confirmed.
- Systematic systemic treatment with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use of pleural effusion) was given within 2 weeks before the first administration.
Received live attenuated vaccine within 4 weeks before the first administration (or planned to receive live vaccine during the study period);
Note: Inactivated (killed) virus vaccines for seasonal influenza are allowed within 4 weeks before the first administration, but live attenuated influenza vaccines are not allowed.
- Patients had undergone large and medium-sized operations or unhealed surgical incisions, ulcers or fractures within 4 weeks before the first administration.
- Patients who were undergoing any other forms of immunosuppressive therapy, not including local glucocorticoids or physiological dose of systemic glucocorticoids (<10 mg/day prednisone or equivalent doses of glucocorticoids) through nasal spray, inhalation or other routes, within 7 days before the first administration.
- Patients had a history of non-infectious pneumonia requiring glucocorticoid therapy or currently have interstitial lung disease one year before the first administration.
- Active autoimmune diseases requiring systemic treatment (e.g. using the disease-relieving drugs, corticosteroids or immunosuppressants) occurred within two years before the first administration. Allow the use of alternative therapies (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiencies).
- Patients with Asymptomatic central nervous metastasis; For patients who had stable symptoms (> 2 weeks) after treatment of brain metastases, they can participate in this study as long as they meet all the following criteria: there are measurable lesions outside the central nervous system; no metastases of the midbrain, pons, cerebellum, medulla oblongata or spinal cord; no history of intracranial hemorrhage in the past; stop the discontinuation of hormone therapy 7 days before the medication treatment;
- Before the start of treatment, patients who had not been fully recovered from the toxicity and/or complications caused by any intervention (i.e., less than grade 1 or reaching the baseline, excluding fatigue or alopecia);
- Patients who had the uncontrollable third interstitial effusion (e.g. pleural effusion/pericardial effusion).
- Patients who had any unstable systemic disease: including but not limited to active infections, unstable angina pectoris, cerebrovascular accident or transient ischemic attack (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure [New York Heart Association (NYHA) Classification >Class II], severe arrhythmias requiring medication treatment, liver, kidney or metabolic disease;
- Patients who had received solid organ or blood system transplantation, except corneal transplantation.
- A known history of human immunodeficiency virus (HIV) infection (i.e. positive HIV 1/2 antibody);
- Active or current tuberculosis requiring medical intervention, including but not limited to tuberculosis;
- Patients who had untreated active hepatitis B; Note: Hepatitis B patients could be included in this research if they meet the following criteria:
- The hepatitis B virus (HBV) load must be less than 1000 copies/ml (200 IU/ml) before the first administration. Anti-HBV therapy should be taken throughout the study period to avoid viral reactivation. For subjects who had HBcAb (+), HBsAg (-), HBsAb (-), HBsAb (-) and HBV viral load (-), no prophylactic anti-HBV treatment is required, but virus reactivation needs to be closely monitored.
- Subjects with active hepatitis c virus (HCV) infection (HCV antibody positive and HCV-RNA level higher than the detection limit);
- Subjects who had severe allergic reactions (> grade 3) to the active ingredients and any excipients of Sindelimab, Anlotinib hydrochloride.
- Pregnant or lactating women or women preparing for pregnancy or lactation during the study period;
- For men or women at risk of conception, and they disagree with the application of effective contraception during the study period and within 90 days after the last administration.
- Patients who had a history of alcoholism or drug abuse;
- Other conditions that researchers considered not suitable for including in this research.
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:Anlotinib Combined With Sintilimab
Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, Combined With Sintilimab 200mg/time,21-day cycle。
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Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, Combined With Sintilimab 200mg/time,21-day cycle。
他の名前:
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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 |
---|---|---|
Progress free survival
時間枠:At least 1 year following the conclusion of immunotherapy
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PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
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At least 1 year following the conclusion of immunotherapy
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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 |
---|---|---|
Overall Survival
時間枠:At least 1 year following the conclusion of immunotherapy
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Overall Survival is defined as the length of time from random assignment to death or to last contact.
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At least 1 year following the conclusion of immunotherapy
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Objective Response Rate
時間枠:At least 1 year following the conclusion of immunotherapy
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Objective response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1)
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At least 1 year following the conclusion of immunotherapy
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協力者と研究者
捜査官
- 主任研究者:Tong Zhou、Changzhou Cancer Hospital of Soochow University
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
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