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Camrelizumab Combined With Apatinib in the Treatment of Advanced Sarcomatoid Carcinoma or Carcinosarcoma

2022年3月1日 更新者:Fudan University

A Multicenter, Open, Single Arm, Phase II Clinical Study of Camrelizumab Combined With Apatinib in the Treatment of Advanced Sarcomatoid Carcinoma or Carcinosarcoma

This study is to explore the treatment of advanced sarcomatoid carcinoma or Carcinosarcoma with Carrelizumab combined with Apatinib, in order to provide guidance and experience for new combined therapy in clinic.

研究概览

详细说明

A number of clinical studies have shown that PD-1 immunotherapy combined with anti-vascular target drugs has achieved good clinical efficacy in primary liver cancer, nasopharyngeal carcinoma, esophageal cancer and other tumors. For sarcomatoid carcinoma, which is a rare tumor with large heterogeneity, poor treatment effect and poor prognosis, clinicians are facing great confusion on how to find a good treatment regimen in clinic. The purpose of this study is to explore the treatment of advanced sarcomatoid carcinoma with PD-1 antibody Camrelizumab combined with anti-vascular target drug Apatinib.

研究类型

介入性

注册 (预期的)

45

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Shanghai
      • Shanghai、Shanghai、中国、200032
        • 招聘中
        • Fudan University Shanghai Cancer Center
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age 18 ~ 75 years old, and gender is not limited;
  2. Advanced patients with sarcomatoid carcinoma or carcinosarcoma confirmed by histopathology;
  3. Patients with sarcomatoid carcinoma who have not received systematic drug treatment or have received first-line treatment;
  4. The physical condition score (PS) of Eastern cancer cooperation group (ECoG) was 0 ~ 2;
  5. The expected survival time is more than 3 months;
  6. Within 7 days (including 7 days) before screening, the laboratory test data shall be Calculation: neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 90 × 109 / L, hemoglobin ≥ 90g / L (no blood transfusion within 14 days), total serum bilirubin ≤ 1.25 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 x ULN (patients with liver metastasis ≤ 5x ULN); Serum creatinine ≤ 1.25 x ULN;
  7. Measurable lesions (RECIST 1.1 standard);
  8. The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study.

Exclusion criteria

Those who have one or more of the following are not eligible for this study:

  1. Patients who have previously received anti-vascular targeted drugs or PD-1 mAb;
  2. Received any experimental drugs or antitumor drugs within 4 weeks before enrollment; History of other tumors in the past five years, except cured cervical cancer or skin basal cell carcinoma;
  3. Symptomatic brain or meningeal metastasis (unless the patient has received treatment for > 6 months, the imaging result is negative within 4 weeks before entering the study, and the clinical symptoms related to the tumor are stable at the time of entering the study);
  4. Clinically significant active bleeding;
  5. Pregnant or lactating women; Those who are fertile and do not take adequate contraceptive measures;
  6. Alcohol or drug addiction;
  7. Patients with active or history of autoimmune diseases that may recur (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, etc.), or patients with high risk (such as organ transplantation and immunosuppressive treatment). Except for autoimmune hypothyroidism requiring hormone replacement therapy only or skin diseases without systemic treatment.
  8. Patients requiring systemic corticosteroids (equivalent to > 10mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment or during the study. Use topical or inhaled glucocorticoids, or use glucocorticoids for short-term (≤ 7 days) to prevent or treat non autoimmune and infrequent allergic diseases.
  9. Important organ failure or other serious diseases, including interstitial pneumonia, clinically related coronary artery disease, cardiovascular disease, or myocardial infarction, congestive heart failure, unstable angina pectoris, symptomatic pericardial effusion or unstable arrhythmia within 6 months before enrollment;
  10. Have a history of infection with human immunodeficiency virus, or suffer from other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation or stem cell transplantation;
  11. Patients with chronic hepatitis B or active hepatitis C. HBV carriers, stable hepatitis B after treatment (DNA titer less than 103 copies /ml) and cured hepatitis C patients (negative for HCV RNA test) can be enrolled.
  12. Serious neurological or psychiatric history; Severe infection; Active disseminated intravascular coagulation or other concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study according to the judgment of the investigator.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Camrelizumab Combined With Apatinib

Apatinib tablets: 250mg qd.po, 4 weeks as a cycle, continuous medication until disease progression, death or intolerable toxicity;

Camrelizumab: administered intravenously with a fixed dose of 200mg, administered intravenously (without preventive medication), each infusion for 30min (no less than 20min, no more than 60min), administered once every two weeks until disease progression, death or intolerable toxicity. The maximum period is 2 years.

The curative effect was evaluated every 8 weeks.

After signing the informed consent, the selected patients received Camrelizumab combined with Apatinib. Treatment until disease progression and intolerable adverse reactions occur
其他名称:
  • PD-1 immunotherapy and VEGFR-TKIs

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
反应率
大体时间:CR 和 PR 患者的比率,通过研究完成,平均 1 年
客观反应率
CR 和 PR 患者的比率,通过研究完成,平均 1 年

次要结果测量

结果测量
措施说明
大体时间
操作系统
大体时间:从签署 ICF 到因任何原因死亡之日,评估最长 36 个月
总生存期
从签署 ICF 到因任何原因死亡之日,评估最长 36 个月
无进展生存期
大体时间:从签署 ICF 到第一次记录进展日期或任何原因死亡日期,以先到者为准,评估长达 36 个月
无进展生存期
从签署 ICF 到第一次记录进展日期或任何原因死亡日期,以先到者为准,评估长达 36 个月
AE
大体时间:所有入组患者的不良事件发生率和类型,直至研究完成,平均 1 年
所有入组患者的不良事件
所有入组患者的不良事件发生率和类型,直至研究完成,平均 1 年
直流电阻率
大体时间:CR、PR 和 SD 患者的比率,通过研究完成,平均 1 年
疾病控制率
CR、PR 和 SD 患者的比率,通过研究完成,平均 1 年

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年11月21日

初级完成 (预期的)

2023年3月30日

研究完成 (预期的)

2023年6月30日

研究注册日期

首次提交

2021年11月23日

首先提交符合 QC 标准的

2022年3月1日

首次发布 (实际的)

2022年3月4日

研究记录更新

最后更新发布 (实际的)

2022年3月4日

上次提交的符合 QC 标准的更新

2022年3月1日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Camrelizumab Combined With Apatinib的临床试验

3
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