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Efficacy and Safety of Precision Therapy in Refractory Tumor

2022年2月16日更新者：Baodong Qin

Efficacy and Safety of Precision Therapy in Refractory Tumor (Long March Pathway)

This study is intended to evaluate efficacy and safety of targeted precision therapy in patients with refractory tumor, including rare tumor without standard recommended treatment and common tumor after multiple line of therapy.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The individuals recruited in the present study are with solid tumor, mainly including two parts: first, rare tumor without standard recommended treatment such as atypical fibrous histiocytoma; second, common tumor after multiple line of therapy such as lung cancer, gastric cancer, colorectal cancer, etc. All patients have no any standard therapy based on NCCN guideline when recruiting. Next-generation sequence was used to detect druggable molecular event including gene mutation, gene fusion, amplification, etc. Then patients with molecular events were treated with corresponding targeted drug and followed-up, and not limited tumor type. PD-1/L1 inhibior plus anti-angiogenic agent was used in patients without durgguable targets. The efficacy and safety of these regimens were evaluated.

研究类型

介入性

注册 (预期的)

300

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

姓名：Xiao-dong Jiao, MD.PHD
电话号码：+86-13817797639
邮箱：pulava@163.com

学习地点

中国
- Shanghai
  - Shanghai、Shanghai、中国、200003
    - 招聘中
    - Shanghai Changzheng Hospital

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

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Malignant solid tumors diagnosed histologically;
Common solid tumor patients have no any standard choice after multiple line of therapy; Rare solid tumor did not have any standard recommended treatment;
Expected survival ≥ 1 month;
ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

Patient still has standard treatment therapy based on NCCN guidance;
Patient can not comply with research program requirements or follow-up;

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）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Targeted Drug Therapy Group All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.	药品：Gefitinib Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results. 药品：Erlotinib Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results. 药品：Afatinib Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results. 药品：Trastuzumab Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results. 药品：Oxazolidine Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results. 药品：Olaparib Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results. 药品：Everolimus Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results. 药品：Cabozantinib Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results. 药品：Vemurafenib Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results. 药品：Dabrafenib Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results. 药品：Palbociclib Palbociclib is an FDA/CFDA approved targeted drugs used for CDK4/6 mutation or amplification based on NGS results. 药品：PD-1/L1 inhibitor plus anti-angiogenic agent PD-1/L1 inhibitor plus anti-angiogenic agent is a regimen used for refractory tumor without druggable target

参与者组/臂

干预/治疗

实验性的：Targeted Drug Therapy Group

All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.

药品：Gefitinib

Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.

药品：Erlotinib

Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.

药品：Afatinib

Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.

药品：Trastuzumab

Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results.

药品：Oxazolidine

Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results.

药品：Olaparib

Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results.

药品：Everolimus

Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results.

药品：Cabozantinib

Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results.

药品：Vemurafenib

Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.

药品：Dabrafenib

Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.

药品：Palbociclib

Palbociclib is an FDA/CFDA approved targeted drugs used for CDK4/6 mutation or amplification based on NGS results.

药品：PD-1/L1 inhibitor plus anti-angiogenic agent

PD-1/L1 inhibitor plus anti-angiogenic agent is a regimen used for refractory tumor without druggable target

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
客观反应率大体时间：通过研究完成根据 RECIST 标准评估肿瘤负荷，平均 2 个月	肿瘤负荷减少预定量的患者比例，包括完全缓解和部分缓解	通过研究完成根据 RECIST 标准评估肿瘤负荷，平均 2 个月

次要结果测量

结果测量	措施说明	大体时间
无进展生存大体时间：根据 RECIST 标准评估肿瘤负荷，直到通过研究完成首次记录进展，平均 2 个月	从治疗开始到疾病进展的时间	根据 RECIST 标准评估肿瘤负荷，直到通过研究完成首次记录进展，平均 2 个月
总生存期大体时间：从治疗开始之日到因任何原因死亡之日，到研究完成，平均 1 个月	从治疗开始到因任何原因死亡的时间	从治疗开始之日到因任何原因死亡之日，到研究完成，平均 1 个月
负面影响大体时间：通过学习完成，平均1个月	治疗相关不良事件的发生率	通过学习完成，平均1个月

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。

赞助

Baodong Qin

调查人员

首席研究员：Yuan-Sheng Zang, MD.PHD、Shanghai Changzheng Hospital

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)

2017年1月1日

初级完成 (预期的)

2023年6月30日

研究完成 (预期的)

2023年12月31日

研究注册日期

首次提交

2017年7月28日

首先提交符合 QC 标准的

2017年8月1日

首次发布 (实际的)

2017年8月3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2月16日

最后验证

2022年2月1日

Gefitinib的临床试验

Jiangsu Famous Medical Technology Co., Ltd.

未知

吉非替尼临床试验（非小细胞肺癌）

非小细胞肺癌
China Medical University Hospital
China Medical University, Taiwan

招聘中

尼达尼布联合 EGFR TKI 用于治疗 EGFR 突变的非小细胞肺癌患者

非小细胞肺癌 | 表皮生长因子受体基因突变 | EGFR-TKI 耐药突变

台湾
Sichuan Provincial People's Hospital

未知

EGFR 突变的腺癌颅骨疾病（混合）中的大分割脑放疗 (Hybrid)

IV 期 EGFR 突变的 NSCL 伴脑转移

中国

Efficacy and Safety of Precision Therapy in Refractory Tumor