中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR1900027104
最近更新日期： Date of Last Refreshed on：	2019-10-31 23:16:39
注册时间： Date of Registration：	2019-10-31 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	真实世界中分子肿瘤委员会指导下难治性实体肿瘤个体化精准治疗的前瞻性临床研究
Public title：	Prospective Clinical Study of Individualized Precision Treatment of Refractory Solid Tumors under Guidance of Molecular Tumor Board in Real World
注册题目简写：
English Acronym：
研究课题的正式科学名称：	分子肿瘤委员会指导下难治性实体肿瘤个体化精准治疗的前瞻性真实世界的临床研究
Scientific title：	Prospective Clinical Study of Individualized Precision Treatment of Refractory Solid Tumors under Guidance of Molecular Tumor Board in Real World
研究课题代号(代码)： Study subject ID：	MTB-FST
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	王丽丽	研究负责人：	王海涛
Applicant：	Lili Wang	Study leader：	Haitao Wang
申请注册联系人电话： Applicant telephone：	+86 13920232807	研究负责人电话： Study leader's telephone：	+86 18630955984
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	1511217556@qq.com	研究负责人电子邮件： Study leader's E-mail：	peterrock2000@126.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	天津市河西区平江道23号	研究负责人通讯地址：	天津市河西区平江道23号
Applicant address：	23 Pingjiang Road, Hexi District, Tianjin, China	Study leader's address：	23 Pingjiang Road, Hexi District, Tianjin, China
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	天津医科大学
Applicant's institution：	Tianjin Medical University
研究负责人所在单位：	天津医科大学
Affiliation of the Leader：	Tianjin Medical University

是否获伦理委员会批准：	否
Approved by ethic committee：	No
伦理委员会批件文号： Approved No. of ethic committee：		伦理委员会批件附件： Approved file of Ethical Committee：
批准本研究的伦理委员会名称：
Name of the ethic committee：
伦理委员会批准日期： Date of approved by ethic committee：	2013-08-26 00:00:00
伦理委员会联系人：
Contact Name of the ethic committee：
伦理委员会联系地址：
Contact Address of the ethic committee：
伦理委员会联系人电话： Contact phone of the ethic committee：		伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

博鳌超级医院

Primary sponsor：

Bo'ao Super Hospital

研究实施负责（组长）单位地址：

海南省琼海市中原镇博鳌乐城国际医疗旅游先行区康祥路6号

Primary sponsor's address：

6 Kangxiang Road, Pioneer Area of Boao Lecheng International Medical Tourism, Zhongyuan Town, Qionghai, Hai'nan, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	海南省	市(区县)：	琼海市
Country：	China	Province：	Hai'nan	City：	Qionghai
单位(医院)：	博鳌超级医院	具体地址：	琼海市中原镇博鳌乐城国际医疗旅游先行区康祥路6号
Institution hospital：	Bo'ao Super Hospital	Address：	6 Kangxiang Road, Pioneer Area of Boao Lecheng International Medical Tourism, Zhongyuan Town, Qionghai

经费或物资来源：

无

Source(s) of funding：

No

研究疾病：

实体肿瘤

Target disease：

Solid Tumor

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

晚期恶性肿瘤患者，失去了手术治疗等最佳治疗机会，虽然内分泌治疗、化疗、免疫治疗、分子靶向治疗、微创手术治疗等多学科综合疗法能够肿瘤患者的预后，但晚期肿瘤患者的复发、转移仍是他们主要的死亡原因。结合基因测序技术，从病因学上对晚期难治性肿瘤患者进行分型, 针对不同分型采取临床个体化治疗是急需的。随着二代测序技术的高速发展，基于生物标记物指导更多的患者从中受益。MTB（Molecular Tumor Board）是指由分子生物学，病理学，肿瘤学、生物信息学等多学科形成的治疗团队为NGS测序后肿瘤患者提供治疗决策。MTB指导下的诊疗模式更有助患者个体化治疗管理。我们期许NGS（(Next Generation Sequencing）测序后MTB指导下的治疗模式能为患者带来新的治疗希望。

Objectives of Study：

Patients with advanced malignant tumors have lost the best treatment opportunities such as surgery, although multidisciplinary treatments such as endocrine therapy, chemotherapy, immunotherapy, molecular targeted therapy, and minimally invasive surgery can prognosis of cancer patients, but recurrence of advanced tumor patients Transfer is still the main cause of death. Combined with gene sequencing technology, it is necessary to classify patients with advanced refractory tumors from the etiology. It is urgent to take individualized treatment for different types. With the rapid development of second-generation sequencing technology, biomarkers are used to guide more patients to benefit from it. MTB（Molecular Tumor Board） refers to a multidisciplinary treatment team formed by molecular biology, pathology, oncology, and bioinformatics to provide treatment decisions for tumor patients after NGS sequencing. The diagnosis and treatment model under the guidance of MTB is more helpful for individualized treatment management. We expect that the treatment mode under the guidance of MTB after NGS sequencing will bring new therapeutic hopes to patients.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Aged >=18 years old;
2. Patients can provide detailed clinical baseline information including: name, age, gender, pathology, past treatment, etc.;
3. ECOG 0-4;
4. The estimated total survival period is not less than 12 weeks;
5. Patients with solid tumors diagnosed by pathology, including patients with solid tumors of unknown origin;
6. Refractory solid tumors are mainly defined as solid tumor patients without standard treatment before enrollment or no treatment after multi-line treatment failure;
7. The patient is able to receive treatment advice from the Molecular Oncology Committee;
8. Specific molecular characteristics The treatment group was previously unable to receive treatment with related inhibitors including the following:
Group A: After the NGS sequencing, the MTB expert committee determined that there were harmful mutations in the PI3K/AKT/mTOR pathway genes (such as AKT, mTOR, TSC1, TSC2, etc.) and that the main clone features were not previously treated with this pathway inhibitor;
Group B: After the NGS sequencing, the MTB expert committee judged that there were harmful mutations in Homologous Recombination (HR) genes (such as BRCA1/2, PALB2, ATM, ATR, RAD51, etc.) and the main clones had not been accepted before. PARP inhibitor treatment;
Group C: After the NGS sequencing, the MTB expert committee judged that there was a missense mutation of the TP53 gene and the main clone had not been treated with PARP inhibitor and VEGFR inhibitor before;
Group D: After the NGS sequencing, the MTB expert committee judged that there was harmful variation of BRAF/MEK gene and the main clone did not receive excessive target kinase inhibitor treatment and BRAF/MEK and other related inhibitors.
Group E: After the NGS sequencing of the patient, the MTB expert committee determined that there was a harmful mutation in the CDK12 gene and the main clone was either TMB-H or Mismatch Repair Deficient (MRD). The expression of PD-L1 was not previously accepted. Immunosuppressive drug therapy;
Group F: Other molecular features identified by the MTB expert group and previously not treated with recommended drugs;
9. Can provide NGS data approved by the Molecular Oncology Committee;
10. Imaging examination has at least one measurable lesion with a diameter >=10 mm;
11. Be able to follow the research and follow-up procedures to provide real and effective information;
12. The follow-up period must be at least greater than 2 months;
13. The patient or his legal guardian understands the test procedure and content and voluntarily signs the Informed Consent Forms (ICF).

排除标准：

1.无自知能力的患者及精神异常者；
2.其它严重疾病或状况；
1)严重、未控制的内科疾病及感染
2)严重的不能控制的消化系统紊乱
3)严重的电解质紊乱
4)活动性播散性血管内凝血
5)主要器官功能衰竭，如失代偿性心、肺、肝、肾功能衰竭
6)其它研究者认为因严重疾病不能入组者；
3.不能耐受相应分子靶向治疗及拒绝其他一切治疗者；
4.同时采用其他试验药物或正在其他临床试验中；
5.研究者认为不适宜的患者（依从性不好，不能随访等因素）。

Exclusion criteria：

1. Patients with no self-awareness and mental disorders;
2. Other serious diseases or conditions;
1) Severe, uncontrolled medical conditions and infections;
2) Severe uncontrollable digestive disorders;
3) Severe electrolyte imbalance;
4) Active disseminated intravascular coagulation;
5) Major organ failure, such as decompensated heart, lung, liver, kidney failure;
6) Other investigators believe that they cannot be enrolled because of serious illness;
3. Can not tolerate the corresponding molecular targeted therapy and reject all other treatments;
4. At the same time using other test drugs or in other clinical trials;
5. Patients who are considered inappropriate by the investigator (inferior compliance, inability to follow up, etc.).

研究实施时间：

Study execute time：

从 From 2019-11-10 00:00:00至 To 2022-11-10 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2019-11-10 00:00:00 至 To 2020-11-10 00:00:00

干预措施：

Interventions：

组别：	分子肿瘤委员会指导治疗组	样本量：	100
Group：	Molecular Tumor Board Guided Treatment Group	Sample size：	100
干预措施：	靶向药物治疗	干预措施代码：
Intervention：	Targeted drug therapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	海南省	市(区县)：	琼海市
Country：	China	Province：	Hai'nan	City：	Qionghai
单位(医院)：	博鳌超级医院	单位级别：	三级
Institution hospital：	Bo'ao Super Hospital	Level of the institution：	Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：	客观缓解率	指标类型：	主要指标
Outcome：	Objective Response Rate, ORR	Type：	Primary indicator
测量时间点：		测量方法：	实体肿瘤的疗效评价标准1.1 版
Measure time point of outcome：		Measure method：	Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

指标中文名：	无疾病进展生存	指标类型：	次要指标
Outcome：	Progress Free Survival, PFS	Type：	Secondary indicator
测量时间点：		测量方法：	实体肿瘤的疗效评价标准1.1 版
Measure time point of outcome：		Measure method：	Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

指标中文名：	疗效持续时间	指标类型：	次要指标
Outcome：	Duration of Response, DOR	Type：	Secondary indicator
测量时间点：		测量方法：	实体肿瘤的疗效评价标准1.1 版
Measure time point of outcome：		Measure method：	Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

指标中文名：	疾病控制率	指标类型：	次要指标
Outcome：	Disease Control Rate, DCR	Type：	Secondary indicator
测量时间点：		测量方法：	实体肿瘤的疗效评价标准1.1 版
Measure time point of outcome：		Measure method：	Response Evaluation Criteria in Solid Tumors RECIST Version 1.1

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	Overall Survival, OS	Type：	Secondary indicator
测量时间点：	36月	测量方法：	随访
Measure time point of outcome：	36 months	Measure method：	Follow-up

指标中文名：	安全性相关指标	指标类型：	次要指标
Outcome：	Safety related indicators	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	Blood	Tissue：
人体标本去向	使用后保存	说明
Fate of sample：	Preservation after use	Note：

标本中文名：	组织	组织：	根据肿瘤位置
Sample Name：	Tissue	Tissue：	According to tumor location
人体标本去向	使用后保存	说明
Fate of sample：	Preservation after use	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

非随机

Randomization Procedure (please state who generates the random number sequence and by what method)：

Non randomized

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	N/A
Blinding：	N/A
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	no
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	病例记录表或电子病例
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form（ CRF）or Electronic case
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2019-10-31 23:16:39