ChiCTR2400088200 版本V1.0 版本创建时间2024/08/13 11:48:08 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400088200 

最近更新日期：

Date of Last Refreshed on：

2024-08-13 11:47:18 

注册时间：

Date of Registration：

2024-08-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

伏美替尼联合化疗一线治疗EGFR突变局部晚期或转移性非小细胞肺癌患者的前瞻性、单臂临床研究

Public title：

A prospective, single-arm clinical study of furmonertinib combined with chemotherapy in the first-line treatment of patients with EGFR mutant locally advanced or metastatic non-small cell lung cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

伏美替尼联合化疗一线治疗EGFR突变局部晚期或转移性非小细胞肺癌患者的前瞻性、单臂临床研究

Scientific title：

A prospective, single-arm clinical study of furmonertinib combined with chemotherapy in the first-line treatment of patients with EGFR mutant locally advanced or metastatic non-small cell lung cancer

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：

张乐蒙 

研究负责人：

张乐蒙 

Applicant：

Lemeng Zhang 

Study leader：

zhang lemeng 

申请注册联系人电话：

Applicant telephone：

+86 18684689890

研究负责人电话：

Study leader's telephone：

+86 18684689890

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：

zhanglemeng@hnca.org.cn

研究负责人电子邮件：

Study leader's E-mail：

zhanglemeng@hnca.org.cn

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：

长沙市岳麓区湖南省肿瘤医院13楼胸部内一科

研究负责人通讯地址：

咸嘉湖路582号

Applicant address：

Department of Thoracic Medicine, 13th Floor, Hunan Cancer Hospital, Yuelu District, Changsha City

Study leader's address：

283 Tongzipo Road, Yuelu District, Changsha City

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：

湖南省肿瘤医院

Applicant's institution：

Hunan Cancer Hospital

研究负责人所在单位：

湖南省肿瘤医院

Affiliation of the Leader：

hunan cancer hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024科审31号、2024科研简易程序审查95号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

湖南省肿瘤医院医学伦理审查委员会

Name of the ethic committee：

Medical Ethics Review Committee of Hunan Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-06-20 00:00:00

伦理委员会联系人：

杨凤

Contact Name of the ethic committee：

Yang Feng

伦理委员会联系地址：

咸嘉湖路582号

Contact Address of the ethic committee：

283 Tongzipo Road, Yuelu District, Changsha City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 731 89762695

伦理委员会联系人邮箱：

Contact email of the ethic committee：

hnszlyy_irb@163.com

研究实施负责（组长）单位：

湖南省肿瘤医院

Primary sponsor：

hunan cancer hospital

研究实施负责（组长）单位地址：

咸嘉湖路582号

Primary sponsor's address：

283 Tongzipo Road, Yuelu District, Changsha City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

Country：

China

Province：

Hunan

City：

单位(医院)：

湖南省肿瘤医院

具体地址：

咸嘉湖路582号

Institution
hospital：

hunan cancer hospital

Address：

283 Tongzipo Road, Yuelu District, Changsha City

经费或物资来源：

湖南省科技厅自然科学基金;湖南省卫生健康委员会;长沙市科技局自然科学基金项目;广东省临床试验协会/中国胸部肿瘤研究协作组和广东省肺癌转化医学重点实验室开放课题;上海艾力斯医药科技股份有限公司

Source(s) of funding：

National Natural Science Foundation of China;Hunan Provincial Health Commission;Natural Science Foundation Project of Changsha Science and Technology Bureau;Guangdong Clinical Trial Association/China Thoracic Tumour Research Collaboration Group and Guangdon;Shanghai Allist Pharmaceuticals Co., Ltd.

Target disease：

EGFR mutation positive locally advanced or metastatic non-small cell lung cancer

Target disease code：

研究类型：

干预性研究

Study type：

Interventional 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：

评估伏美替尼联合化疗一线治疗EGFR突变阳性的晚期非小细胞肺癌患者的疗效及安全性  

Objectives of Study：

Evaluating the efficacy and safety of furmonertinib in combination with chemotherapy for the first-line treatment of patients with EGFR mutation-positive advanced non-small cell lung cancer

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1) 在任何研究具体程序之前提供知情同意；
2) 年龄在18 岁以上(含 18 岁)；
3) ECOG 体力状况评分为 0-1 并且在入组之前 2 周没有恶化，预期寿命为≥12 周；
4) 经组织学或细胞学确诊为非鳞非小细胞肺癌；
5) 经研究者评估，不可或不适宜手术切除，且不可或不适宜行根治性放疗的局部晚期或转移性非鳞非小细胞肺癌（AJCC第8版TNM分期为IIIB-IV期）；
6) 有三级甲等医院出具或认定的组织学或细胞学证实为存在EGFR 19DEL或L858R突变，以上突变可单独存在或共同存在；
7) 患者在首次研究方案治疗开始前未接受过针对晚期/转移性非小细胞肺癌的系统性抗肿瘤治疗，包括化疗、生物治疗、靶向治疗、免疫治疗、或者试验性药物治疗；接受过辅助治疗或新辅助治疗（化疗和/或放疗）的患者，如果治疗后6个月内 没有进展，允许入组；对于接受过局部治疗(放疗或胸膜腔灌注治疗) 的患者，如果局部治疗范围内的病灶为非靶病灶，允许入组；
8) 根据RECIST1.1，受试者至少有一处既往未经过照射，也没有在筛选期接受过组织活检，可准确测量的病灶；如果受试者有且只有一个可测量病灶，允许该病灶进行组织活检，但该病灶的基线影像学检查应在组织活检至少14天后进行；
9) 在首次研究方案治疗开始前至少 2 周，女性受试者应使用高度有效的避孕措施 （见限制规定），妊娠试验必须为阴性，并且在开始研究方案治疗前没有正在进行的母乳喂养，或者否则必须在筛选时满足以下标准之一，证明没有生育能力的可能性；
1.? 绝经后定义为年龄超过 50 岁，停止所有外源激素治疗后闭经至少12 个月；
2.? 50 岁以下的女性如果在停用外源性激素治疗后停经12个月或更长时间，并且促黄体生成素（LH）和卵泡刺激素（FSH）水平处于该机构的绝经后范围内，则应视为停经；
3.? 通过子宫切除术、双侧卵巢切除术或双侧输卵管切除术记录的不可逆的手术绝育， 但不包括输卵管结扎术；
10）男性受试者应该愿意使用屏障避孕，即避孕套（见限制规定）；
11）能够依从研究方案及随访程序的要求，并能接受口服药物治疗；

Inclusion criteria

1) Provide informed consent prior to any study specific procedures;
2) at least 18 years of age（including 18 years）;
3) ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks, life expectancy ≥12 weeks;
4) Pathologically confirmed non-squamous Non-Small Cell Lung Cancer (NSCLC);
5) Locally advanced or metastatic non-squamous non-small cell lung cancer (AJCC 8th edition TNM stage IIIB-IV) that is not amenable or appropriate for surgical resection and is not amenable or appropriate for radical radiotherapy, as assessed by the investigator;
6) Histological or cytological confirmation of the presence of the EGFR 19DEL or L858R mutation, either alone or in combination, from a tertiary care hospital.
7) Patients who have not received systemic anti-tumour therapy for advanced/metastatic non-small cell lung cancer, including chemotherapy, biologic therapy, targeted therapy, immunotherapy, or experimental drug therapy prior to the initiation of treatment with the first study regimen; patients who have received adjuvant or neoadjuvant therapy (chemotherapy and/or radiotherapy) are allowed to be enrolled if there has been no progression within 6 months of treatment; and for patients who have received localised therapy (radiotherapy or For patients who have received localised therapy (radiotherapy or pleural cavity perfusion), enrolment is allowed if the lesion within the scope of localised therapy is a non-target lesion;
8) Subjects with at least one accurately measurable lesion that has not been previously irradiated and has not received a tissue biopsy during the Screening Period according to RECIST 1.1; if a subject has one and only one measurable lesion, tissue biopsy of that lesion is permitted, provided that the baseline imaging of that lesion is performed at least 14 days after tissue biopsy;
9) At least 2 weeks prior to the start of treatment on the first study protocol, female subjects should be using highly effective contraception (see limitations), must have a negative pregnancy test and not be breastfeeding ongoing prior to the start of treatment on the study protocol or otherwise must meet one of the following criteria at the time of screening, demonstrating that there is no likelihood of fertility;
1.? Postmenopausal is defined as age over 50 years with amenorrhoea for at least 12 months after cessation of all exogenous hormone therapy.
2.? Women under 50 years of age should be considered to have ceased menstruation if they have ceased menstruation for 12 months or more after discontinuing exogenous hormone therapy and have luteinising hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range of the institution;
3.? Irreversible surgical sterilisation documented by hysterectomy, bilateral salpingo-oophorectomy or bilateral salpingo-oophorectomy, excluding tubal ligation;
10）Male subjects should be willing to use barrier contraception, i.e. condoms (see restrictions);
11）Ability to comply with the requirements of the study protocol and follow-up procedures and to receive oral medication;

排除标准：

1) 病理类型为肺鳞状细胞癌或肺小细胞癌；
2) 已知对于伏美替尼/顺铂或卡铂/培美曲塞的有活性或无活性辅料或有试验药物类似结构或类别的药物的超敏反应史；
3) 有确证的EGFR外显子20插入突变；
4) 在首次研究方案治疗开始前，接受过以下任何治疗的患者；
1.? 任何EGFR-TKI治疗；
2.? 接受过胸膜腔内灌注治疗的患者，需在胸水稳定后 28 天及以上才可入组；
3.? 首次研究方案治疗开始前 28 天内接受过大手术（在中国，外科大手术的定义参照 2009 年 5 月 1 日施行的《医疗技术临床应用管理办法》中规定的 3 级和 4 级手术，详见附录 5）；
4.? 首次研究方案治疗开始前 28 天内，接受过照射区域≥30%骨髓或广范围的放疗，首次研究方案治疗开始前 14 天内接受过局部放疗或针对骨转移的姑息性放疗；
5.? 7 天内接受过 CYP3A4 强效抑制剂或强效诱导剂，或研究期间需要继续接受这些药物治疗的患者（药物名单详见附录 6）；
6.? 7 天内接受过以抗肿瘤为适应症的中药及中成药制剂，或研究期间需要继续接受这些药物治疗的患者（药物名单详见附录 7）；
7.? 正在接受已知可延长 QTc 间期或可能导致尖端扭转性室性心动过速的药物治疗，且研究期间需要继续接受这些药物治疗的患者（药物名单详见附录 8）；
8.? 停用其他临床试验性药物的时间未满 5个半衰期或2个月（以较长者为准）；
5) 首次研究方案治疗开始前，既往抗肿瘤治疗相关的毒性未恢复至≤ CTCAE1级，脱发或者化疗引起的≤ CTCAE2级外周神经毒性除外；
6) 存在脊髓压迫或有症状的脑转移；无症状、病情稳定、研究治疗开始前不需要使用类固醇药物治疗满14天及以上者除外，接受过脑转移局部放疗的患者，需在放疗结束后，脑转移症状稳定14天及以上才能入组；
7) 胸腔积液情况不稳定的患者；
8) 最近5年内罹患其他恶性肿瘤或有其他恶性肿瘤病史, 已经得到有效控制的皮肤基底细胞癌、宫颈原位癌和乳腺导管原位癌除外；
9) 近期活动性消化性疾病，如十二指肠溃疡，溃疡性结肠炎、回肠炎等，肠穿孔，肠瘘，或其他有研究者酌情规定的可能导致胃肠道出血或穿孔的情况；或有难治性恶心呕吐，慢性胃肠道疾病，无法吞咽研究药物，或既往行大肠癌切除术等妨碍伏美替尼充分吸收的情况；
10) 存在任何重度或不受控制的全身性疾病的证据，包括未控制的高血压、糖尿病和活动性出血等，研究者认为任何不利于患者参与研究或破坏方案的依从性， 或包括乙型肝炎、丙型肝炎和人类免疫缺陷病毒（HIV）在内的活动性感染（包括任何接受静脉注射治疗感染的患者；活动性乙肝感染至少包括所有 基于血清学评估乙肝表面抗原呈阳性且乙肝病毒 DNA＞1000 拷贝/ml 的患者）；
11) 间质性肺病病史、药物引起的间质性肺病、需要类固醇治疗的放射性肺炎的既往病史或活动性间质性肺病的任何证据；
12) 已知存在角膜损伤的任何证据；
13) 首次研究方案治疗开始前 28 天内检查显示缺乏足够的骨髓储备或器官功能 (检查前2周内，未输血或血制品、未使用粒细胞集落刺激因子或其它造血刺激 因子纠正)；
9.? 嗜中性粒细胞绝对计数<1.5×10^9/L，血小板计数<100×10^9/L，血红蛋白<90 g/L；
10.? 丙氨酸转氨酶> 2.5 倍 ULN，天冬氨酸转氨酶>2.5 倍 ULN，总胆红素> 1.5 倍 ULN，或肝转移患者AST 和/或 ALT > 5倍 ULN；
11.? 血清肌酐>1.5 倍 ULN，肌酐清除率<50 mL/min [由 Cockcroft 和 Gault 公式测量或计算]，见附录2）；
12.? 国际标准化比(INR)> 1.5，且部分活化凝血酶原时间(APTT)>1.5×ULN；
14）以下任何心脏标准：；
13.? 静息状态下，3 次心电图（ECG）检查获得的平均静息校正 QT间期（QTc）>470 毫秒，以 Fridericia 公式计算，详见附录 9；
14.? 首次研究方案治疗开始前28天内任何具有临床意义的静息心电图的节律、传导或形态异常，例如左束支传导阻滞、三度心脏传导阻滞和二度心脏传导阻滞；
15.? 首次研究方案治疗开始前28天内心功能评估：LVEF＜50%，最近6个月内有心肌梗塞、严重或不稳定心绞痛病史或冠脉搭桥手术史或心功能不全等级≥NYHA 2（附录 10）；
15）妊娠或哺乳；
16）由研究者判定的不能参加本研究的患者，如大概率无法遵守研究章程、约束和要求的患者；或研究者酌情判断的其他情况；

Exclusion criteria：

1) Pathological type of squamous cell carcinoma of the lung or small cell carcinoma of the lung;
2) Known history of hypersensitivity reactions to active or inactive excipients of furmonertinib/cisplatin or carboplatin/pemetrexed or to drugs of similar structure or class to the test drug;
3) With confirmed EGFR exon 20 insertion mutations;
4）Patients who have received any of the following treatments prior to the start of treatment on the first study protocol：;
1.? Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) treatment;
2.? The patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after the pleural effusion is stable;
3.? Major surgery within 28 days prior to the start of treatment on the first study protocol (in China, major surgical procedures are defined as Grade 3 and 4 procedures as defined in the Measures for the Administration of Clinical Application of Medical Technology, which came into force on 1 May 2009, see Appendix 5 for details);
4.? Radiotherapy to ≥30% of the bone marrow or extensive radiotherapy to an irradiated area within 28 days prior to the start of treatment on the first study protocol, and local radiotherapy or palliative radiotherapy for bone metastases within 14 days prior to the start of treatment on the first study protocol;
5.? CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose, or need to receive these drugs during the study period;
6.? Traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications and with adjuvant treatment of tumor is used within 7 days prior to the first dose, or need to receive these drugs during the study period(See Appendix 7 for a detailed list of drugs);
7.? Patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to continue to receive these drugs during the study period(See Appendix 8 for a detailed list of drugs);
8.? The time from the treatment with any other investigational product or its analogue to the first dose does not exceed 5 half-lives of the drug or 14 days, whichever is longer;
5) At the beginning of study treatment, any unresolved toxic reaction to prior treatment is present, which exceeds Grade 1 in accordance with Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for prior platinum treatment-related neuropathy;
6) Presence of spinal cord compression or symptomatic brain metastases; with the exception of those who are asymptomatic, stable, and do not require treatment with steroids for 14 days or more prior to the start of study treatment, and those who have received local radiotherapy for brain metastases, who need to be stable with symptoms of brain metastases for 14 days or more after the completion of radiotherapy to be eligible for enrolment;
7） Patients with unstable pleural effusions;
8) Diagnosed other malignant tumors or had a history of other malignant tumors in last 5 years, except for skin basal cell carcinoma, cervical carcinoma in situ and breast ductal carcinoma in situ which have been effectively controlled;
9) Recent active digestive diseases such as duodenal ulcer, ulcerative colitis, ileitis, intestinal perforation, intestinal fistula, or other conditions that may cause gastrointestinal bleeding or perforation as the researchers may prescribe. Or refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of furmonertinib;
10) Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes mellitus, active bleeding, etc., which in the opinion of the investigator is not conducive to participation in the study or undermines adherence to the regimen, or active infection including hepatitis B, hepatitis C, and Human Immunodeficiency Virus (HIV) (including any patient infected with an IVRT infection; active Hepatitis B infection of at least (including any patient infected with IV therapy; active Hepatitis B infection includes all patients who are serologically positive for Hepatitis B surface antigen and have more than 1000 copies of Hepatitis B virus DNA/ml);
11) Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease;
12) Any evidence of known corneal injury;
13) Lack of adequate bone marrow reserve or organ function on examination within 28 days prior to the start of treatment on the first study protocol (not corrected by transfusion of blood or blood products, granulocyte colony-stimulating factor, or other haematopoietic stimulating factor within 2 weeks prior to the examination);
9.? Absolute neutrophil count <1.5 x 10^9/L, platelet count <100 x 10^9/L, haemoglobin <90 g/L;
10.? Alanine aminotransferase > 2.5 times ULN, aspartate aminotransferase > 2.5 times ULN, total bilirubin > 1.5 times ULN, or AST and/or ALT > 5 times ULN in patients with liver metastases;
11.? Serum creatinine >1.5 times ULN, creatinine clearance <50 mL/min [measured or calculated by the Cockcroft and Gault formula], see Appendix 2);
12.? International normalised ratio (INR) > 1.5 and partially activated prothrombin time (APTT) > 1.5 x ULN;
14）Any of the following cardiac criteria:;
13.? Mean resting corrected QT interval (QTc) >470 ms obtained from 3 electrocardiograms (ECGs) at rest, calculated using the Fridericia formula, as detailed in Appendix 9;
14.? Any clinically significant rhythm, conduction or morphological abnormality of the resting ECG within 28 days prior to the start of treatment on the first study protocol, e.g. left bundle branch block, third degree heart block and second degree heart block;
15.? Assessment of cardiac function 28 days prior to the start of treatment on the first study protocol: LVEF <50%, history of myocardial infarction, severe or unstable angina pectoris, or coronary artery bypass grafting within the last 6 months or grade of cardiac insufficiency ≥NYHA 2 (Appendix 10);
15）Pregnancy or breastfeeding;
16）Patients who, in the judgement of the investigator, are unable to participate in this study, e.g. patients with a high probability of not being able to comply with the study charter, constraints and requirements; or other circumstances in the judgement of the investigator at their discretion;

研究实施时间：

Study execute time：

从 From 2024-08-01 00:00:00至 To 2028-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-08-13 00:00:00 至 To 2025-08-13 00:00:00  

干预措施：

Interventions：

组别：

伏美替尼联合化疗

样本量：

51

Group：

furmonertinib combined with chemotherapy

Sample size：

干预措施：

伏美替尼 80mg QD连续给药联合培美曲塞+顺铂/卡铂 Q3W 4周期

干预措施代码：

Intervention：

furmonertinib combined with chemotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China 

Province：

Hunan 

City：

 

单位(医院)：

湖南省肿瘤医院 

单位级别：

三级甲等 

Institution
hospital：

hunan cancer hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

overall survival

Type：

Secondary indicator

测量时间点：

从第一名患者入组起后约48个月

测量方法：

从患者入组开始到任何原因死亡时间

Measure time point of outcome：

approximately 48 months from the first patient being enrolled

Measure method：

Time from enrolled to death from any cause

指标中文名：

客观缓解率

指标类型：

次要指标

Outcome：

Objective Response Rate

Type：

Secondary indicator

测量时间点：

从第一名患者入组起后约36个月

测量方法：

根据《实体瘤反应评估标准 1.1 版》（RECIST 1.1），采用研究者评估）定义为完全缓解或部分缓解的患者人数（%）。客观缓解率的评估将包括直至疾病进展或未出现疾病进展时的最后一次可评估数据。

Measure time point of outcome：

approximately 36 months from the first patient being enrolled

Measure method：

per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with response of Complete Response or Partial Response. Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of Objective Response Rate

指标中文名：

疾病无进展生存期

指标类型：

主要指标

Outcome：

Disease progression-free survival

Type：

Primary indicator

测量时间点：

从第一名患者入组起后约36个月

测量方法：

无进展生存期（PFS）由研究者根据实体瘤反应评估标准 1.1 版（RECIST 1.1）进行评估。无进展生存期（PFS）是指从研究治疗开始到客观疾病进展或死亡（未出现进展的患者因任何原因死亡）的时间。

Measure time point of outcome：

approximately 36 months from the first patient being enrolled

Measure method：

Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression)。

指标中文名：

疾病控制率

指标类型：

次要指标

Outcome：

Disease Control Rate

Type：

Secondary indicator

测量时间点：

从第一名患者入组起后约36个月

测量方法：

疾病控制率（DCR）是指经研究者评估（持续时间≥ 6 周），根据实体瘤反应评估标准 1.1 版（RECIST 1.1），获得完全缓解（CR）或部分缓解（PR）或疾病稳定（SD）的最佳总体缓解的受试者百分比。

Measure time point of outcome：

approximately 36 months from the first patient being enrolled

Measure method：

Disease control rate (DCR) is defined as the percentage of subjects who have a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator (duration ≥ 6 weeks).

指标中文名：

安全性

指标类型：

次要指标

Outcome：

Safety

Type：

Secondary indicator

测量时间点：

从第一名患者入组起后约36个月

测量方法：

研究人员将根据 CTCAE 5.0 进行分析，评估联合治疗的安全性。

Measure time point of outcome：

approximately 36 months from the first patient being enrolled

Measure method：

An analysis will be performed to assess the safety of combination therapy according to CTCAE 5.0 as assessed by the Investigator

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

外周血

组织：

Sample Name：

Peripheral blood

Tissue：

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 99 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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)：

/

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：

电子病例报告表

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

Electronic case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-08-13 11:47:18