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扶正抗癌方联合检查点抑制剂治疗晚期非小细胞肺癌的疗效与安全性研究：一项随机双盲对照试验

注册号：

Registration number：

ITMCTR2023000032

最近更新日期：

Date of Last Refreshed on：

2023-08-23

注册时间：

Date of Registration：

2023-08-23

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

扶正抗癌方联合检查点抑制剂治疗晚期非小细胞肺癌的疗效与安全性研究：一项随机双盲对照试验

Public title：

Efficacy and safety of Fuzheng Kangai granule combined with immune checkpoint inhitbitor for advanced non-small cell lung cancer: a randomized, double-blind, placebo-controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

扶正抗癌方联合检查点抑制剂治疗晚期非小细胞肺癌的疗效与安全性研究：一项随机双盲对照试验

Scientific title：

Efficacy and safety of Fuzheng Kangai granule combined with immune checkpoint inhitbitor for advanced non-small cell lung cancer: a randomized, double-blind, placebo-controlled trial

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

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：

陈继欣

研究负责人：

Applicant：

Jixin Chen

Study leader：

Xiaobing Yang

申请注册联系人电话：

Applicant telephone：

15918556373

研究负责人电话：

Study leader's telephone：

13580309705

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：

1006570604@qq.com

研究负责人电子邮件：

Study leader's E-mail：

yangxiaobing2002@126.com

申请单位网址(自愿提供)：

Study leader's 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：

广州市白云区机场路12号（）

研究负责人通讯地址：

Applicant address：

Airport road No.12, Baiyun district, Guangzhou, Guangdong, China

Study leader's address：

Dade road No.111, Yuexiu district, Guangzhou, Guangdong, 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：

Applicant's institution：

Guangzhou university of Chinese medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

BF2021-241-01

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

Name of the ethic committee：

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2021/12/21 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Li Xiaoyan

伦理委员会联系地址：

Contact Address of the ethic committee：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong

伦理委员会联系人电话：

Contact phone of the ethic committee：

020-81887233

伦理委员会联系人邮箱：

Contact email of the ethic committee：

llbgs@gzucm.edu.cn

研究实施负责（组长）单位：

Primary sponsor：

Guangdong Provincial Hospital of Chinese Medicine

研究实施负责（组长）单位地址：

Primary sponsor's address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

具体地址：

Institution
hospital：

Guangdong Provincial Hospital of Chinese Medicine

Address：

111 Dade Road, Yuexiu District

经费或物资来源：

Source(s) of funding：

the State Key Laboratory of Dampness Syndrome of Chinese Medicine (SZ2021ZZ38)

研究疾病：

研究疾病代码：

Target disease：

non-small cell lung cancer (NSCLC)

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

Objectives of Study：

To clarify the efficacy and safety of Fuzheng Kangai granule combined with PD-1 inhibitor in the treatment of advanced NSCLC without gene mutation and with positive PD-L1 expression

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

(a) Patients who were confirmed advanced primary NSCLC (stage IIIb, IIIc, IVa, or IVb) by histology or cytology according to the 8th TNM classification of lung cancer without gene mutation and with positive PD-L1 expression; (b) Age from 18 to 80 years; (d) Life expectancy over 3 months; (e) Existing at least one measurable lesion; (f) Eastern Cooperative Oncology Group (ECOG) performance status less than 2 scores; (g) Meeting the indication of using PD-1 inhibitor; (h) Signing informed consent and participating in the study voluntarily.

排除标准：

Exclusion criteria：

(a) Participating in another interventional clinical study currently or within 4 weeks; (b) Prior immunotherapy; (c) Performing a major surgery within 3 weeks; (d) Using a long-term systemic corticosteroid; (e) Severe infection using antibiotics; (f) Dysphagia; (g) An active autoimmune disease requiring systemic treatment occurred within 2 years; (h) Currently pregnant or breastfeeding; (i) Symptomatic central nervous system metastases.

研究实施时间：

Study execute time：

从From 2021-11-18

至To      2026-12-31

征募观察对象时间：

Recruiting time：

从From 2023-01-01

至To      2026-06-30

干预措施：

Interventions：

组别：

样本量：

240

Group：

Experimental group

Sample size：

干预措施：

干预措施代码：

Intervention：

PD-1 inhibitor ± chemotherapy + Fuzheng Kangai granule

Intervention code：

组别：

样本量：

240

Group：

Control group

Sample size：

干预措施：

干预措施代码：

Intervention：

PD-1 inhibitor ± chemotherapy + placebo granule

Intervention code：

样本总量 Total sample size ： 480

研究实施地点：

Countries of recruitment
and research settings：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

单位级别：

Institution/hospital：

Guangdong Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

指标类型：

次要指标

Outcome：

incidence of adverse events

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Follow-up

Measure method：

Adverse Event Report Form/Serious Adverse Event Report Form

指标中文名：

指标类型：

次要指标

Outcome：

1-year survival rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

One year from the initial intervention

Measure method：

Recording surviving cases

指标中文名：

指标类型：

次要指标

Outcome：

quality of life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Before initial intervention and follow-up

Measure method：

Karnofsky performance status

指标中文名：

指标类型：

主要指标

Outcome：

progression free survival

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

From initial intervention to the first appearance of objective tumor progression or death

Measure method：

Primary indicator

指标中文名：

指标类型：

次要指标

Outcome：

overall survival

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

From initial intervention to death

Measure method：

Recording days

指标中文名：

指标类型：

次要指标

Outcome：

objective response rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Follow-up imaging evaluation

Measure method：

Imaging evaluation

指标中文名：

指标类型：

次要指标

Outcome：

disease control rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Follow-up imaging evaluation

Measure method：

Imaging evaluation

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

excrement

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

标本中文名：

组织：

Sample Name：

urine

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

标本中文名：

组织：

Sample Name：

blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 80 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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

The randomized block design was applied to this trial. According to the sequence of enrolling in this study, patients are allocated to 2 blocks with 240 cases in each block. And then, patients in each block would be allocated randomly to two intervention groups. A random-allocation sequence was generated via a computer by the third-party statistician based on the methods of randomized block design. The block numbers, random numbers, and grouping numbers were saved by the leader and the sponsor.

盲法：

Blinding：

A double-blind design was used in this trial. Neither patients nor all investigators (including the statistician, clinical observer, and assistants) knew/ the intervention accepted by patients. Besides, the application of a matched placebo granule which was highly like the FZKA granule in appearance and taste would ensure the blinding. The random numbers and the grouping numbers would be sent to Tianjiang Pharmaceutical Co., Ltd. to prepare relevant granules. And the random numbers were only found on the surface of each pack of granules in two groups. Emergency letters were preserved with the test drug in each center. When opening the emergency letter, the clinical observer should write down the date and reasons on the envelope and inform the leader and sponsor immediately. The blinding was carried out until the entire study has been completed. The leader and sponsor were responsible for unblinding at that time.

是否共享原始数据：

IPD sharing：

否

No

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）：

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NA

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：

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

A Case report form (CRF) is designed to collect the relevant data. Two assistants are responsible for filling out the CRF and inputting data into EXCEL software (Microsoft, America) separately. The clinical observer is responsible for verifying the accuracy of data recording and a statistician is responsible for checking the accuracy of data entry. All data will be managed by the supervisor.

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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