ChiCTR2100049361 版本V1.5 版本创建时间2022/03/12 17:02:54 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：

ChiCTR2100049361 

最近更新日期：

Date of Last Refreshed on：

2022-03-12 16:55:24 

注册时间：

Date of Registration：

2021-08-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

信迪利单抗联合含铂化疗用于复发、持续或转移性宫颈癌的II期、单臂临床研究

Public title：

Phase II Single Arm Study of Combination Sintilimab and Platinum-based Chemotherapy in Patients with Recurrent, Persistent, or Metastatic Cervical Cancer

注册题目简写：

信迪利单抗联合含铂化疗一线治疗宫颈癌

English Acronym：

Combination Sintilimab and Platinum-based Chemotherapy in Patients With Cervical Cancer for First-line Treatment

研究课题的正式科学名称：

信迪利单抗联合含铂化疗用于复发、持续或转移性宫颈癌的II期、单臂临床研究

Scientific title：

Phase II Single Arm Study of Combination Sintilimab and Platinum-based Chemotherapy in Patients with Recurrent, Persistent, or Metastatic Cervical 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：

冉晓敏 

研究负责人：

冉晓敏 

Applicant：

Ran Xiaomin 

Study leader：

Ran Xiaomin 

申请注册联系人电话：

Applicant telephone：

+86 13787223096

研究负责人电话：

Study leader's telephone：

+86 13787223096

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：

404667814@qq.com

研究负责人电子邮件：

Study leader's E-mail：

404667814@qq.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：

湖南省长沙市岳麓区桐梓坡路283号

研究负责人通讯地址：

湖南省长沙市岳麓区桐梓坡路283号

Applicant address：

283 Tongzipo Road, Yuelu District, Changsha, Hu'nan

Study leader's address：

283 Tongzipo Road, Yuelu District, Changsha, Hu'nan

申请注册联系人邮政编码：

Applicant postcode：

410013

研究负责人邮政编码：

Study leader's postcode：

410013

申请人所在单位：

湖南省肿瘤医院

Applicant's institution：

Hu'nan Cancer Hospital

研究负责人所在单位：

湖南省肿瘤医院

Affiliation of the Leader：

Hu'nan 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：

ky202111

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委员会

Name of the ethic committee：

Medical Ethics Committee of Hu'nan Cancer Hospital

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：

湖南省长沙市岳麓区桐梓坡路283号

Contact Address of the ethic committee：

283 Tongzipo Road, Yuelu District, Changsha, Hu'nan

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：

湖南省肿瘤医院

Primary sponsor：

Hu'nan Cancer Hospital

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区桐梓坡路283号

Primary sponsor's address：

283 Tongzipo Road, Yuelu District, Changsha, Hu'nan

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)：

长沙

Country：

China

Province：

Hu'nan

City：

Changsha

单位(医院)：

湖南省肿瘤医院

具体地址：

岳麓区桐梓坡路283号

Institution
hospital：

Hu'nan Cancer Hospital

Address：

283 Tongzipo Road, Yuelu District

经费或物资来源：

企业资助

Source(s) of funding：

Company sponsored

Target disease：

Cervical Cancer

Target disease code：

C53

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：

主要目的： 评估信迪利单抗联合含铂化疗治疗复发、持续性、晚期宫颈癌的客观缓解率（ORR）。 次要目的： RECIST1.1评估的无进展生存期（PFS）； RECIST1.1评估的持续缓解率（DOR）； RECIST1.1评估的疾病控制率（DCR）； 总生存期（OS）； 采用CTCAE 5.0标准评价信迪利单抗联合含铂化疗的安全性和耐受性：包括不良事件（AE）和严重不良事件（SAE）的发生率，AE/SAE导致治疗终止的发生率。 探索性目的： 肿瘤免疫标志物（包括但不限于PD-L1表达水平等）与疗效的相关性。  

Objectives of Study：

Main purpose: To evaluate the objective response rate (ORR) of sindilizumab combined with platinum-containing chemotherapy in the treatment of recurrent, persistent and advanced cervical cancer. Secondary objective: Progression-free survival (PFS) as assessed by RECIST1.1; Duration of response (DOR) assessed by RECIST1.1; Disease Control Rate (DCR) assessed by RECIST1.1; Overall survival (OS); CTCAE 5.0 criteria were used to evaluate the safety and tolerability of Sindillizumab in combination with platinum-containing chemotherapy, including the incidence of adverse events (AE) and serious adverse events (SAE), and the incidence of AE/SAE resulting in treatment termination. Exploratory purpose: Correlation tumor immune-related biomarkers and efficacy (including but not limited to PD-L1 expression levels).

药物成份或治疗方案详述：

受试者将接受信迪利单抗联合含铂化疗治疗，信迪利单抗200mg Q3W。含铂化疗根据研究者根据患者情况选择： TP方案：紫杉醇/顺铂 第一种，第1天 紫杉醇 135 mg/m^2 iv 24 小时；第2天 顺铂 50 mg/m^2 iv ，Q3W； 第二种，第1天 紫衫醇 175 mg/m^2 iv 3小时；第1天 顺铂 50 mg/m^2 iv ，Q3W； TC方案：紫杉醇/卡铂 第1天 紫衫醇 175 mg/m^2 iv 3小时， 卡铂AUC 5 mg/mL/min，Q3W； 信迪利单抗在化疗之前给药，化疗4-6个周期；信迪利单抗一直用至疾病进展或者出现不可耐受的毒性、接受新的抗肿瘤治疗、撤销知情同意书、失访或死亡、或其他研究者判断的应该停止治疗的情况，已先发生者为准。信迪利单抗最长治疗时间为24个月。 

Description for medicine or protocol of treatment in detail：

Subjects will receive sindilizumab 200mg Q3W in combination with platinum-containing chemotherapy. Platinum-containing chemotherapy was selected according to the researcher and the patient's condition: TP regimen: Paclitaxel/ Cisplatin 1.Paclitaxel 135 mg/m^2 iv over 24 hrs on day 1 Cisplatin 50 mg/m^2 iv on day 2; 2.Paclitaxel 175 mg/m^2 iv over 3 hrs on day 1 Cisplatin 50 mg/m^2 iv on day 2; TC regimen: Paclitaxel/ Carboplatin On day 1, Zenitol 175 mg/m^2 iv 3 h, carboplatin AUC 5 mg/mL/min, Q3W; Sintilimab was administered prior to chemotherapy, and in combination with it for 4-6 cycles; Sintilimab is used until disease progression or unacceptable toxicity, new antitumor therapy, withdrawal of informed consent, loss of follow-up or death, or other circumstances that the investigator determines should be discontinued. The longest treatment time of Cindillizumab is 24 months. 

纳入标准：

1.理解研究步骤和内容，并自愿签署书面知情同意书；
2.年龄18~75岁的女性；
3.经病理组织学确诊的未经治疗的IVB期或者复发、持续性宫颈癌（鳞状细胞癌、腺癌、腺鳞状细胞癌），不适合手术和/或放疗；如果放疗野内复发且满足RECIST 1.1的目标病灶于放疗野内，则放疗结束后必须超过3个月才能纳入组；
4.根据实体肿瘤疗效评价标准（RECIST 1.1版），至少有一处影像学可测量病灶；
5.ECOG PS评分为0-1；
6.有充分的器官和骨髓功能，筛查所做的实验室检查必须符合下列标准：
1)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；
2)近14天内未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对计数（ANC）>=1.5x10^9/L；
3)近14天内未输血情况下，血小板（PLT）>=90x10^9/L；
4)总胆红素（TBIL）<=1.5x正常值上限（ULN）（Gilbert 综合征允许 <=3xULN）；
5)谷丙转氨酶（ALT）和谷草转氨酶（AST）<=2.5xULN（如存在肝脏转移，则ALT 和AST<=5xULN）；
6)血清肌酐(Cr) <= 1.5xULN 或内生肌酐清除率>= 50mL/min （Cockcroft-Gault 公式）；
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）；
7.预计生存超过3个月；
8.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；
9.如存在受孕风险，所有受试者均需在整个治疗期间直至治疗末次研究药物给药后120天内采用年失败率低于1%的避孕措施。

Inclusion criteria

1.Written informed consent obtained prior to any study specific procedures.
2. female, 18 to 75 Years old
3. Patients must have histologically confirmed recurrent, persistent or metastatic (primary stage IVB) squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy. If relapsed lesion in radiotherapy field meet RECIST 1.1, it must be more than 3 months after radiotherapy before be included
4. All patients must have measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6.Subjects should have abnormal organ function and meet the following laboratory criteria:
(1) Hemoglobin content >9g/dL in the case of that patients have no blood transfusion or use of erythropoietin during the last 14 days;
(2) Absolute Neutrophil Count (ANC) ≥1.5x109/L in the case of that patients have not use granulocyte colony stimulating factor during the last 14 days.

(3) Platelet count ≥90×109/L in the case of that patients have no blood transfusion during the last 14 days.
(4) Total bilirubin ≤1.5× upper limit of normal value (ULN)( Gilbert syndrome allowed ≤3×ULN)
(5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (ALT and AST≤5×ULN if liver metastasis)
(6) Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥50 mL /min;
(7) Good coagulation function, defined as INR or prothrombin time (PT) ≤1.5 × ULN
(8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is beyond the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can be included.
(9) Myocardial enzyme spectrum was within the normal range (only laboratory abnormalities with no clinical significance were allowed to be included if comprehensively judged by the researcher);
7.Life expectancy of at least 3 months.
8. For female subjects of reproductive age, a urine or serum pregnancy test should be negative and should be performed within 3 days prior to the first study drug administration (cycle 1 day 1). If a urine pregnancy test cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age were defined as those more than one year after menopauseor having undergone sterilization operation or hysterectomy.
9.If there is a risk of pregnancy, all subjects (both men and women) should use contraceptives throughout the treatment period and up to 120 days after the last study drug treatment (or 180 days after the last chemotherapy drug treatment), and contraceptives must be with an annual failure rate less than 1% .

排除标准：

1.首次给药前5年内诊断为宫颈癌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.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；本研究中的重大手术定义是，手术后至少需要3周的恢复时间才能接受本研究中接受的手术。
8.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）；
9.已知异体器官移植（角膜移植除外）或异体造血干细胞移植；
10.已知对本研究药物信迪利单抗活性成分或辅料过敏者；
11.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）；
12.已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2抗体阳性）；
13.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：
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治疗期间接受抗HBV治疗避免病毒再激活
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
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）；
14.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。
15.妊娠或哺乳期妇女；
16.存在任何严重或不能控制的全身性疾病，例如：
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；
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；
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；
血压控制不理想（收缩压>150 mmHg，舒张压>100 mmHg）；
活动性肺结核；
存在需要全身性治疗的活动性或未能控制的感染；
存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻；
肝脏疾病如肝硬化、失代偿性肝病、急性或慢性活动性肝炎；
糖尿病控制不佳（空腹血糖（FBG）>10mmol/L）；
尿常规提示尿蛋白>=++，且证实24小时尿蛋白定量>1.0 g者；
存在精神障碍且无法配合治疗的患者；
17.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：

Subjects meeting the following criteria will not be included in the study:
1.Other malignant tumors were diagnosed within 5 years prior to the first dose, with the exception of radical cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ;
2.Currently participating in interventional clinical research or treatment, or receiving other research drugs or using research equipment within 4 weeks before the first dose;
3.Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or against another stimulatory or synergistic inhibition of T cell receptors [eg CTLA-4 (Cytotoxic T lymphocyte antigen-4), OX-40 (also called CD134, cluster of differentiation134), CD137] agent;
4．Received a traditional Chinese medicine with anti-tumor effect, or an immunomodulatory drug (thymosin, interferon, interleukin) within 2 weeks before the first dose,
5．Active autoimmune diseases requiring systemic treatment (eg, using a disease-modifying drug, corticosteroid or immunosuppressant) within 2 years prior to the first dose. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments;
6.Diagnosis of immunodeficiency or study of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study.
Physiological doses of corticosteroids (≤10 mg/day of prednisone or equivalent) are permitted;
7.Has undergone or planed to undergo major surgery within 4 weeks prior to the administration of the first study drug (except for surgery for biopsy purposes); Major surgery in this study was defined as a recovery time of at least 3 weeks after surgery.
8. Clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not need drainage or have no significant increase in effusion after 3 days of cessation of drainage can be enrolled);

9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
10. known to be allergic to the active ingredient or excipients of Sintilimab
11. Has not fully recovered from toxicity and/or complications from any intervention before starting treatment (i.e., recover means grade ≤1 or reached baseline, excluding fatigue or hair loss)
12. A history of human immunodeficiency virus (HIV) infection (ie, HIV 1/2 antibody positive) is known.
13. Untreated active hepatitis B;
Note: Controlled (treated) hepatitis B subjects also meet the inclusion criteria if the following criteria are met:
At least 4 weeks of HBV (Hepatitis B virus) antiviral therapy must have been received prior to the first dose of study drug, and the HBV viral load is <1000 copies/ml (200 IU/ml). Subjects who are receiving HBV therapy and have a viral load of <1000 copies/ml (200 IU/ml) should receive antiviral therapy throughout the study treatment period.
For subjects with anti-HBc (hepatitis B core antigen)(+), HBsAg(-), anti-HBs(-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation is closely monitored;
Active HCV (Hepatitis C virus)-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
14. Vaccination of live vaccine within 30 days before the first dose (1st cycle, 1st day); Note: Inactivated virus vaccines for seasonal influenza, injectable drugs are permitted; however, live attenuated influenza vaccines are not allowed for intranasal administration;
15.Pregnant or breast feeding women
16. The presence of any serious or uncontrollable systemic disease, such as:
1) There are serious and difficult controlled abnormalities in rhythm, conduction or morphology of the resting electrocardiogram , such as complete left bundle branch block, ≥Grade Ⅱ heart block, ventricular arrhythmia or atrial fibrillation.
2)Unstable angina, congestive heart failure, New York Heart Association (NYHA) ≥ Grade 2 chronic heart failure.
3) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months before enrollment;
4) Poor blood pressure control (systolic pressure > 150 mmHg, diastolic pressure > 100 mmHg)
5)A history of non-infectious pneumonia requiring glucocorticoid therapy or current clinically active interstitial lung disease within 1 year before enrollment
6) Active phthisis
7) Active or uncontrolled infections that require systemic treatment
8) Clinical active diverticulitis, abdominal abscess and gastrointestinal obstruction
9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
10) Poor diabetes control (fasting blood-glucose(FBG) > 10mmol/L
11) Routine urianlysis indicated that urine protein ≥++, and confirmed the 24-hour urine protein > 1.0 g
12）Patients with mental disorders who are unable to comply with treatment
17. Patients with medical history or abnormal therapeutic or laboratory test values that may interfere with study results, impact subjects to participate throughout the study. Patients with other conditions that the investigator considers is unsuitable for inclusion and exsist other potential risks unsuitable for inclusion.

研究实施时间：

Study execute time：

从 From 2021-08-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-08-01 00:00:00 至 To 1990-01-01 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

20

Group：

Experimental group

Sample size：

干预措施：

信迪利单抗联合化疗

干预措施代码：

Intervention：

Sindilizumab 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)：

 长沙 

Country：

China 

Province：

Hu'nan 

City：

Changsha 

单位(医院)：

湖南省肿瘤医院 

单位级别：

三级甲等 

Institution
hospital：

Hu'nan 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：

每6周一次

测量方法：

实体肿瘤的疗效评价标准 1.1 版

Measure time point of outcome：

Every 6 weeks

Measure method：

Efficacy evaluation criteria for solid tumors version 1.1

指标中文名：

无疾病进展时间

指标类型：

次要指标

Outcome：

Progression-free survival (PFS)

Type：

Secondary indicator

测量时间点：

每6周一次

测量方法：

实体肿瘤的疗效评价标准 1.1 版

Measure time point of outcome：

Every 6 weeks

Measure method：

Efficacy evaluation criteria for solid tumors version 1.1

指标中文名：

缓解持续时间

指标类型：

次要指标

Outcome：

Duration of response

Type：

Secondary indicator

测量时间点：

从开始缓解到再次进展

测量方法：

实体肿瘤的疗效评价标准 1.1 版

Measure time point of outcome：

From the beginning of remission to progress again

Measure method：

Efficacy evaluation criteria for solid tumors 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

Type：

Secondary indicator

测量时间点：

从入组到开始出现最佳缓解

测量方法：

Measure time point of outcome：

From Enroll until to optimal remission

Measure method：

指标中文名：

总生存

指标类型：

次要指标

Outcome：

Overall survival

Type：

Secondary indicator

测量时间点：

从入组到死亡

测量方法：

Measure time point of outcome：

From enrollment to death

Measure method：

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：

从开始治疗到最后一次治疗后30天

测量方法：

Measure time point of outcome：

From the start of treatment to the last treatment with 30 days

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

肿瘤组织

组织：

宫颈

Sample Name：

tumor tissue

Tissue：

cervix uteri

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 75 岁 years

性别：

女性

Gender：

Female

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)：

nonrandom

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：

Blinding：

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）：

不适用

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

不适用

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：

不适用

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

不适用

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-08-01 09:08:39