ChiCTR2200055419 版本V1.5 版本创建时间2023/01/30 00:07:23 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：

 ChiCTR2200055419 

最近更新日期：

Date of Last Refreshed on：

 2022-08-19 21:23:47 

注册时间：

Date of Registration：

 2022-01-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

信迪利单抗联合盐酸安罗替尼和双药化疗一线治疗晚期恶性胸膜间皮瘤患者安全性和疗效的临床研究

Public title：

A clinical study on the safety and efficacy of sintilimab combined with anlotinib hydrochloride and double-drug chemotherapy in the first-line treatment of patients with advanced malignant pleural mesothelioma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

信迪利单抗联合盐酸安罗替尼和双药化疗一线治疗晚期恶性胸膜间皮瘤患者安全性和疗效的临床研究

Scientific title：

A clinical study on the safety and efficacy of sintilimab combined with anlotinib hydrochloride and double-drug chemotherapy in the first-line treatment of patients with advanced malignant pleural mesothelioma

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：

段建春 

研究负责人：

段建春 

Applicant：

Duan Jianchun 

Study leader：

Duan Jianchun 

申请注册联系人电话：

Applicant telephone：

 +86 13811259820

研究负责人电话：

Study leader's
telephone：

+86 13811259820

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：

 duanjianchun79@163.com

研究负责人电子邮件：

Study leader's E-mail：

 duanjianchun79@163.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：

北京市朝阳区潘家园南里17号

研究负责人通讯地址：

北京市朝阳区潘家园南里17号

Applicant address：

17 Panjiayuan Lane South, Chaoyang District, Beijing

Study leader's address：

17 Panjiayuan Lane South, Chaoyang District, Beijing

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：

中国医学科学院肿瘤医院

Applicant's institution：

Chinese Academy of Medical Sciences Cancer Hospital

研究负责人所在单位：

中国医学科学院肿瘤医院

Affiliation of the Leader：

Chinese Academy of Medical Sciences Cancer Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 21/233-2904

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：

中国医学科学院肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of Cancer Hospital, Chinese Academy of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-05-13 00:00:00

伦理委员会联系人：

吴大维

Contact Name of the ethic committee：

Wu Dawei

伦理委员会联系地址：

北京市朝阳区潘家园南里17号

Contact Address of the ethic committee：

17 Panjiayuan Lane South, Chaoyang District, Beijing

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：

中国医学科学院肿瘤医院

Primary sponsor：

Cancer Hospital, Chinese Academy of Medical Sciences

研究实施负责（组长）单位地址：

北京市朝阳区潘家园南里17号

Primary sponsor's address：

17 Panjiayuan Lane South, Chaoyang District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国医学科学院肿瘤医院

具体地址：

朝阳区潘家园南里17号

Institution
hospital：

Cancer Hospital, Chinese Academy of Medical Sciences

Address：

17 Panjiayuan Lane South, Chaoyang District

经费或物资来源：

吴阶平医学基金会临床科研专项资助基金

Source(s) of funding：

Wu Jieping Medical Foundation Special Fund for Clinical Research

研究疾病：

肺癌  

Target disease：

Lung Cancer

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 II期临床试验 

Study phase：

2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

观察和评价信迪利单抗联合盐酸安罗替尼和双药化疗一线治疗晚期恶性胸膜间皮瘤的有效性和安全性。  

Objectives of Study：

To observe and evaluate the efficacy and safety of sintilimab combined with anlotinib hydrochloride and double-drug chemotherapy in the first-line treatment of advanced malignant pleural mesothelioma.

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.在实施任何试验相关流程之前，签署书面知情同意；
2.年龄≥18岁；
3.组织学确诊，不可切除或无法手术或局部晚期（IIIB期）、复发或转移性（IV期）恶性胸膜间皮瘤（pleural mesothelioma）；
4.根据改良版的实体肿瘤疗效评价标准（mRECIST 1.1版），至少有一处影像学可测量病灶；
5.既往未接受过针对晚期/转移性疾病的任何系统性抗肿瘤治疗。对于既往曾接受过含铂辅助/新辅助化疗，或针对进展期疾病接受过根治性放化疗的患者，如疾病进展或复发与末次化疗药物治疗结束间隔至少6个月以上，允许入组本研究；
6.允许无症状或经局部治疗后症状稳定的脑转移患者入组，只要患者满足以下条件：
（1）中枢神经系统之外有可测量病灶；
（2）无中枢神经系统症状或至少2周内症状无加重；
（3）无需糖皮质激素治疗或首次研究药物给药前7天内停用糖皮质激素治疗者；
7.允许患者接受姑息性放疗，但放疗结束时间在首次研究药物给药前7天内；
8.ECOG评分0-1分；
9.预期生存时间>3个月；
10.足够器官功能，受试者需满足如下实验室指标：
（1）近14天未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对值（ANC）≥1.5x10^9/L；
（2）近14天未输血的情况下，血小板≥100×10^9/L；
（3）近14天内无输血或使用促红细胞生成素的情况下，血红蛋白>9g/dL；
（4）总胆红素≤1.5×正常值上限（ULN）；如总胆红素>1.5×ULN但直接胆红素≤ ULN也允许入组；
（5）天门冬氨酸转氨酶（AST）、丙氨酸转氨酶（ALT）在≤2.5×ULN（有肝转移的患者允许ALT 或AST ≤5×ULN）；
（6）血肌酐≤1.5×ULN并且肌酐清除率（采用Cockcroft-Gault 公式计算）≥60 ml/min；
（7）凝血功能良好，定义为国际标准化比值（INR）或凝血酶原时间（PT）≤1.5倍ULN；
（8）甲状腺功能正常，定义为促甲状腺激素（TSH）在正常范围内。如基线TSH超出正常范围，如果总T3（或FT3）及FT4在正常范围内的受试者亦可入组；
（9）心肌酶谱在正常范围内（如研究者综合判断为不具有临床意义的单纯实验室异常也允许入组）；（可选）
11.对于育龄期女性受试者，应在接受首次研究药物给药（第1周期第1天）之前的3天内接受尿液或血清妊娠试验且结果为阴性。如果尿液妊娠试验结果无法确认为阴性，则要求进行血液妊娠试验。非育龄期女性定义为绝经后至少１年，或进行过手术绝育或子宫切除术；
12.如存在受孕风险，所有受试者（不论男性或女性）均需在整个治疗期间直至治疗末次研究药物给药后120天（或末次化疗药物给药后180天）内采用年失败率低于1%的避孕措施。

Inclusion criteria

1. Sign written informed consent before implementing any trial-related procedures;
2. Aged >= 18 years;
3. Histologically confirmed, unresectable or inoperable or locally advanced (stage IIIB), recurrent or metastatic (stage IV) malignant pleural mesothelioma;
4. According to the modified version of the solid tumor response evaluation criteria (mRECIST version 1.1), at least one lesion can be measured by imaging;
5. Have not received any systemic antitumor therapy for advanced/metastatic disease before. For patients who have received platinum-containing adjuvant/neoadjuvant chemotherapy in the past, or have received radical chemoradiotherapy for advanced disease, such as disease progression or recurrence and the end of the last chemotherapeutic drug treatment, the interval of at least 6 months is allowed to be enrolled in this study;
6. Patients with asymptomatic or stable brain metastases after local treatment are allowed to enroll, as long as the patients meet the following conditions:
(1) Measurable lesions outside the central nervous system;
(2) No central nervous system symptoms or no exacerbation of symptoms for at least 2 weeks;
(3) No need for glucocorticoid therapy or discontinuation of glucocorticoid therapy within 7 days before the first study drug administration;
7. Patients are allowed to receive palliative radiotherapy, but the end of radiotherapy is within 7 days before the first study drug administration;
8. ECOG score 0-1 points;
9. Expected survival time > 3 months;
10. Sufficient organ function, patients should meet the following laboratory indicators:
(1) The absolute value of neutrophils (ANC) is >=1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days;
(2) Platelets >=100x10^9/L without blood transfusion in the past 14 days;
(3) Hemoglobin>9g/dL without blood transfusion or erythropoietin in the past 14 days;
(4) Total bilirubin <= 1.5 x upper limit of normal (ULN); such as total bilirubin > 1.5 x ULN but direct bilirubin <= ULN is also allowed to enter the group;
(5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are <=2.5xULN (patients with liver metastases are allowed ALT or AST <=5xULN);
(6) Serum creatinine <=1.5xULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) >=60 ml/min;
(7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN;
(8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, patients with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
(9) Myocardial enzyme spectrum is within the normal range (if the investigators comprehensively judge that simple laboratory abnormalities that are not clinically significant are also allowed to be included in the group); (optional)
11. For female patients of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy;
12. If there is a risk of pregnancy, all patients (no gender limit) are required to use contraceptive measures with an annual failure rate of less than 1% during the entire treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug).

排除标准：

1.首次给药前5年内诊断为恶性胸膜间皮瘤之外的其他恶性疾病（不包括经过根治的皮肤基底细胞癌、皮肤鳞状上皮癌、和/或经过根治性切除的原位癌）；
2.当前正在参与干预性临床研究治疗，或在首次给药前4周内接受过其他研究药物或使用过研究器械治疗；
3.既往接受过下列疗法：抗PD-1、抗PD-L1或抗PD-L2药物或者针对另一种刺激或协同抑制T细胞受体（例如，CTLA-4、OX-40、CD137）的药物；
4.首次给药前2周内接受过具有抗肿瘤适应症的中成药或免疫调节作用的药物（包括胸腺肽、干扰素、白介素，除外为控制胸水局部使用）系统性全身治疗；
5.首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、糖皮质激素或免疫抑制剂）的活动性自身性免疫疾病。替代疗法（例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性糖皮质激素等）不视为全身性治疗；
6.研究首次给药前7天内正在接受全身性糖皮质激素治疗（不包括喷鼻、吸入性或其他途径的局部糖皮质激素）或任何其他形式的免疫抑制疗法；
注：允许使用生理剂量的糖皮质激素（≤10 mg/天的泼尼松或等效药物）。
7.存在临床上不可控制的胸腔积液/腹腔积液（不需要引流积液或停止引流3天积液无明显增加的患者可以入组）；
8.已知异体器官移植（角膜移植除外）或异体造血干细胞移植；
9.已知对本研究药物信迪利单抗活性成分或辅料过敏者；
10.具有影响口服药物的多种因素（比如无法吞咽、胃肠道切除术后、慢性腹泻和肠梗阻等）者；
11.有症状或不受控制的脑转移；
12.首次研究药物给药前3个月内存在活动性咯血（一次咯出至少2.5ml或1/2茶匙鲜血）；
13.影像显示有肿瘤侵入/浸润大血管或研究者或放射科医生评估有出血倾向；
14.首次研究药物给药前4周内接受过重大手术治疗（以活检为目的的手术除外）或预期在研究期间行重大手术；
15.严重的未愈合的伤口溃疡或骨折；
16.在首次接受研究药物前48小时内进行过小手术（需要使用局部麻醉的门诊/住院手术，包括中心静脉置管）；
17.当前或近期（接受首剂研究药物前10天内）连续10天使用阿司匹林（> 325 mg/天）或其他已知可以抑制血小板功能的非甾体抗炎药；
18.当前或近期（接受首剂研究药物前10天内）连续10天使用全剂量口服或胃肠外抗凝血药或血栓溶解剂进行治疗；
注：允许预防性使用小剂量抗凝血药：在凝血酶原时间国际标准化比值（INR）≤1.5的前提下，允许以预防目的使用小剂量华法林（≤1mg/d），小剂量肝素（≤1.2万U/d）或小剂量阿司匹林（≤100mg/d）。
19.有遗传性出血倾向或凝血功能障碍，或血栓病史；
20.在开始治疗前，尚未从任何干预措施引起的毒性和/或并发症中充分恢复（即，≤1级或达到基线，不包括乏力或脱发）；
21.已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2抗体阳性）；
22.未经治疗的活动性乙肝（定义为HBsAg阳性同时检测到HBV-DNA拷贝数大于所在研究中心检验科正常值上限）；
注：符合下列标准的乙肝受试者亦可入组：
（1）首次给药前HBV病毒载量<1000拷贝/ml（200 IU/ml），受试者应在整个研究药物治疗期间接受抗HBV治疗避免病毒再激活；
（2）对于抗HBc（+）、HBsAg（-）、抗HBs（-）和HBV病毒载量（-）的受试者，不需要接受预防性抗HBV治疗，但是需要密切监测病毒再激活；
23.活动性的HCV感染受试者（HCV抗体阳性且HCV-RNA水平高于检测下限）；
24.首次给药之前（第 1 周期，第 1 天）30 天内接种过活疫苗；
注：允许首次给药前 30 天内接受针对季节性流感的注射用灭活病毒疫苗；但是不允许接受鼻内用药的减毒活流感疫苗。
25.妊娠或哺乳期妇女；
26.存在任何严重或不能控制的全身性疾病，例如：
（1）静息心电图在节律、传导或形态上出现有重大且症状严重难以控制的异常，如完全性左束支传导阻滞，Ⅱ度以上心脏传导阻滞，室性心律失常或心房颤动；
（2）不稳定型心绞痛，充血性心力衰竭，纽约心脏病协会（NYHA）分级≥ 2 级的慢性心衰；
（3）在入选治疗前6个月内发生过任何动脉血栓、栓塞或缺血，如心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等；
（4）血压控制不理想（收缩压＞140 mmHg，舒张压＞90 mmHg）；
（5）首次给药前1年内存在需要糖皮质激素治疗的非感染性肺炎病史，或当前存在临床活动性间质性肺病；
（6）活动性肺结核；
（7）存在需要全身性治疗的活动性或未能控制的感染；
（8）存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻；
（9）肝脏疾病如肝硬化、失代偿性肝病、急性或慢性活动性肝炎；
（10）糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）；
（11）尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者；
（12）存在精神障碍且无法配合治疗的患者；
27.有可能干扰试验结果、妨碍受试者全程参与研究的病史或疾病证据、治疗或实验室检查值异常，或研究者认为其他不适合入组的情况研究者认为存在其他潜在风险不适合参加本研究。

Exclusion criteria：

1. Diagnosed with other malignant diseases other than malignant pleural mesothelioma within 5 years before the first administration (excluding radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and/or radically resected carcinoma in situ) ;
2. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose;
3. Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 drug, or another drug that stimulates or synergistically inhibits T-cell receptors (eg, CTLA-4, OX-40, CD137 );
4. Received systemic systemic treatment of Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration;
5. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy;
6. Those who are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study;
Note: Physiological doses of glucocorticoids (<=10 mg/day prednisone or equivalent) are permitted.
7. There is clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not require drainage of effusion or who have no significant increase in effusion after stopping drainage for 3 days can be enrolled);
8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
9. Those who are known to be allergic to the active ingredients or excipients of the study drug sintilimab;
10. Those with multiple factors that affect oral drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
11. Symptomatic or uncontrolled brain metastases;
12. Active hemoptysis (at least 2.5ml or 1/2 teaspoon of fresh blood was coughed up once) within 3 months before the first study drug administration;
13. Imaging shows tumor invasion/infiltration of large blood vessels or bleeding tendency assessed by investigator or radiologist;
14. Received major surgery within 4 weeks before the first study drug administration (except surgery for biopsy) or is expected to undergo major surgery during the study period;
15. Severe unhealed wound ulcers or fractures;
16. Minor surgery (outpatient/inpatient surgery that requires the use of local anesthesia, including central venous catheterization) within 48 hours before receiving the study drug for the first time;
17. Current or recent (within 10 days before receiving the first dose of study drug) aspirin (> 325 mg/day) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function for 10 consecutive days;
18. Current or recent (within 10 days before receiving the first dose of study drug) for 10 consecutive days with full-dose oral or parenteral anticoagulants or thrombolytics;
Note: Prophylactic use of low-dose anticoagulants is permitted: on the premise that the international normalized ratio (INR) of prothrombin time is <=1.5, low-dose warfarin (<=1 mg/d), low-dose heparin (<=12,000 U/d) or low-dose aspirin ( <=100mg/d).
19. Have hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis;
20. Have not sufficiently recovered from toxicity and/or complications from any intervention (ie, <= Grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment;
21. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive);
22. Untreated active hepatitis B (defined as HBsAg positive and the detection of HBV-DNA copy number greater than the upper limit of the normal value of the laboratory department of the research center);
Note: Hepatitis B patients who meet the following criteria can also be enrolled:
(1) HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, patients should receive anti-HBV therapy during the entire study drug treatment period to avoid viral reactivation;
(2) For patients with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV treatment is not required, but viral reactivation needs to be closely monitored;
23. Active HCV infected patients (HCV antibody positive and HCV-RNA level higher than the detection limit);
24. Received live vaccine within 30 days before the first dose (cycle 1, day 1);
Note: Injected inactivated virus vaccine against seasonal influenza within 30 days prior to the first dose is permitted; however, intranasal live attenuated influenza vaccine is not permitted.
25. Pregnancy or lactation;
26. Presence of any serious or uncontrolled systemic disease such as:
(1) There are significant abnormalities in the rhythm, conduction or morphology of the resting ECG, and the symptoms are severe and difficult to control, such as complete left bundle branch block, second-degree heart block, ventricular arrhythmia or atrial fibrillation;
(2) Unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification >= grade 2;
(3) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, occurred within 6 months before the treatment;
(4) Poor blood pressure control (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg);
(5) There is a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there is currently clinically active interstitial lung disease;
(6) Active pulmonary tuberculosis;
(7) There is an active or uncontrolled infection that requires systemic treatment;
(8) Clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction;
(9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
(10) Poor control of diabetes (fasting blood glucose (FBG) > 10mmol/L);
(11) Urine routine indicates urine protein >=++, and 24-hour urine protein quantification >1.0 g;
(12) Patients with mental disorders and unable to cooperate with treatment;
27. Abnormal medical history or disease evidence, treatment or laboratory test values that may interfere with the test results, prevent patients from participating in the research throughout the study, or the researcher considers other situations that are not suitable for inclusion, or the researcher believes that there are other potential risks and are not suitable to participate in this study.

研究实施时间：

Study execute time：

从 From 2021-11-30 00:00:00至 To 2023-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-01-10 00:00:00 至 To 2023-11-30 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 29

Group：

Experimental group

Sample size：

干预措施：

信迪利单抗联合盐酸安罗替尼和双药化疗

干预措施代码：

Intervention：

Sintilimab combined with anlotinib hydrochloride and doublet chemotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 中国医学科学院肿瘤医院 

单位级别：

 三级甲等 

Institution
hospital：

Chinese Academy of Medical Sciences Cancer Hospital

Level of the institution：

Tertiary A

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

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

无进展生存期

指标类型：

次要指标

Outcome：

Progression-free survival

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

缓解持续时间

指标类型：

次要指标

Outcome：

Duration of relief

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件

指标类型：

副作用指标

Outcome：

Adverse event

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

严重不良事件

指标类型：

副作用指标

Outcome：

Serious adverse event

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗期不良事件

指标类型：

副作用指标

Outcome：

Adverse events during treatment

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

免疫相关不良事件

指标类型：

副作用指标

Outcome：

Immune-related adverse events

Type：

Adverse events

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：

Sample Name：

Tissue

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 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:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

无

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

none

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：

临床试验中的文件（方案和方案修订，完成的 CRF，签署的 ICF 等）需按照GCP 的要求进行保存和管理。研究中心应将这些文件保存到研究结束后 5 年。

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

Documents in clinical trials (protocol and protocol revision, completed CRF, signed ICF, etc.) shall be saved and managed in accordance with the requirements of GCP. The research center shall keep these documents for 5 years after the end of the study.

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：

  2022-01-09 10:22:17