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Adjuvent therapy of locally advanced hypopharyngeal carcinoma, depends on CD8 + T cells and pathological response after induction of immunochemotherapy: a prospective phase II clinical study
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注册号:

Registration number:

ChiCTR2200055939 

最近更新日期:

Date of Last Refreshed on:

2022-01-27 

注册时间:

Date of Registration:

2022-01-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件。 局部晚期下咽癌诱导免疫化疗后依赖CD8+T细胞和病理缓解选择辅助治疗:一项前瞻性II期临床研究 

Public title:

Adjuvent therapy of locally advanced hypopharyngeal carcinoma, depends on CD8 + T cells and pathological response after induction of immunochemotherapy: a prospective phase II clinical study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

局部晚期下咽癌诱导免疫化疗后依赖CD8+T细胞和病理缓解选择辅助治疗:一项前瞻性II期临床研究 

Scientific title:

Adjuvent therapy of locally advanced hypopharyngeal carcinoma, depends on CD8 + T cells and pathological response after induction of immunochemotherapy: a prospective phase II clinical study 

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:

路泽军 

研究负责人:

温居一 

Applicant:

Lu Zejun 

Study leader:

Wen Juyi 

申请注册联系人电话:

Applicant telephone:

18511581845 

研究负责人电话:

Study leader's telephone:

18600310184 

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:

luzejun.01@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wenjuyi@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:

北京市海淀区阜成路6号 

研究负责人通讯地址:

北京市海淀区阜成路6号 

Applicant address:

No. 6, Fucheng Road, Haidian District, Beijing 

Study leader's address:

No. 6, Fucheng Road, Haidian District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100037 

研究负责人邮政编码:

Study leader's postcode:

100037 

申请人所在单位:

中国人民解放军总医院第六医学中心 

Applicant's institution:

The Sixth Medical Center of PLA General Hospital 

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 

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:

中国人民解放军总医院第六医学中心 

Primary sponsor:

The Sixth Medical Center of PLA General Hospital 

研究实施负责(组长)单位地址:

北京市海淀区阜成路6号 

Primary sponsor's address:

No. 6, Fucheng Road, Haidian 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):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

中国人民解放军总医院第六医学中心

具体地址:

北京市海淀区阜成路6号

Institution
hospital:

The Sixth Medical Center of PLA General Hospital

Address:

No. 6, Fucheng Road, Haidian District, Beijing

经费或物资来源:

自筹 

Source(s) of funding:

self-funded 

研究疾病:

下咽癌 

Target disease:

Hypopharyngeal 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:

研究目的:

局部晚期下咽癌中最大程度降低初治患者的复发,有助于提高早期/局晚期患者根治率,帕博利珠单抗治疗复发/转移头颈部鳞癌已证实长期OS获益,免疫治疗为局晚期下咽癌降低复发、降低远处转移提供了理论上的可行性,诱导免疫+化疗在有待开展探索性临床研究。 

Objectives of Study:

Locally advanced hypopharyngeal cancer minimizes the recurrence of newly treated patients, which helps to improve the radical cure rate of early/late stage patients. Pembrolizumab treatment of recurrent/metastatic head and neck squamous cell carcinoma has proven long-term OS benefit, immunotherapy It provides a theoretical feasibility for the reduction of recurrence and distant metastasis of locally advanced hypopharyngeal carcinoma. Induction of immunity + chemotherapy is awaiting exploratory clinical research. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1.组织学或细胞学证实II-IVa期下咽鳞状细胞癌,无复发/转移性疾病: 2.具有可穿刺的病灶; 3.已知PD-L1状态,或可提供肿瘤组织进行PD-L1检测; 4.ECOG评分0-1分; 5.预计生存时间超过3个月; 6.主要器官功能指标符合常规免疫治疗的标准: 中性粒细胞绝对计数≥1.5×109/L;血小板≥100×109/L;血红蛋白≥100 g/L;血清白蛋白≥30 g/L;胆红素≤ULN;ALT 和AST ≤2.5×ULN;如有肝转移,则ALT和AST<5×ULN;血清肌酐≤1.5×ULN;血尿素氮(BUN)≤ 2.5×正常上限(ULN);促甲状腺激素(TSH)≤正常值上限(ULN);如果异常应考察T3和T4水平, T3和T4水平正常则可以入选。 7.育龄期女性受试者愿意在研究期间采用高效避孕措; 8.签署知情同意书。 

Inclusion criteria

1. Organized or cytology confirmed pharyngularized cell carcinoma under II-IVa, no regenerative / metastatic disease: 2. Has a pierced lesion; 3. The PD-L1 state is known, or the tumor tissue can be provided for PD-L1 detection; 4. ECOG rating 0-1 points; 5. The estimated survival time is more than 3 months; 6. The main organ function indicators meet the standards of conventional immunotherapy: Neutrophils absolute count ≥1.5 × 109 / L; platelet ≥ 100 × 109 / L; hemoglobin ≥ 100 g / L; serum albumin ≥ 30 g / L; bilirubin ≤ uln; alt and AST ≤2.5 × ULN If there is liver transfer, Alt and AST <5 × ULN; serum creatinine ≤1.5 × ULN; blood urea nitrogen (BUN) ≤ 2.5 × normal upper limit (ULN); Promotecthyroid hormone (TSH) ≤ normal value upper limit (ULN) If an abnormality should be investigated, T3 and T4 levels, T3 and T4 can be selected. 7. The female subjects for childbearing age are willing to adopt high-efficiency contraceptive measures during the study; 8. Sign informed consent. 

排除标准:

1.不适合局部治疗的患者; 2.存在任何活动性自身免疫病或有自身免疫病病史 3.6个月内接受过放疗、化疗、免疫治疗(PD-1单抗、PD-L1单抗等); 4.筛选前30天内参加过其它干预性临床试验; 5.复发/转移患者; 6.具有其他恶性肿瘤史(已治愈的宫颈原位癌或皮肤基底细胞癌以及已治愈3年以上的其他恶性肿瘤除外); 7.存在控制不佳的并发疾病(如心衰、糖尿病、高血压、甲状腺疾病、精神疾病等); 8.已知感染HIV病毒或活动性病毒性肝炎; 9.正接受慢性类固醇激素治疗超过6个月(如泼尼松剂量> 10 mg/天或同等剂量); 10.对本方案中使用药物或其成分过敏者; 11.妊娠(经血或尿HCG检测确认)或哺乳期妇女; 12.研究者认为不适宜参加本研究者; 

Exclusion criteria:

1. Patients who are not suitable for local treatment; 2. There is any active autoimmune disease or a history of autoimmune disease Received radiotherapy, chemotherapy, immunotherapy (PD-1 monoclonal antibody, PD-L1 monoclonal antibody, etc.) within 3.6 months; 4. Participated in other interventional clinical trials within 30 days before screening; 5. Patients with recurrence/metastasis; 6. History of other malignant tumors (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignant tumors cured for more than 3 years); 7. Poorly controlled concurrent diseases (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); 8. Known to be infected with HIV virus or active viral hepatitis; 9. Are receiving chronic steroid therapy for more than 6 months (such as prednisone dose> 10 mg/day or equivalent dose); 10. Those who are allergic to the drugs or their components used in this program; 11. Pregnant (confirmed by menstrual blood or urine HCG test) or breast-feeding women; 12. The researcher thinks that it is not suitable to participate in this research; 

研究实施时间:

Study execute time:

From2022-01-01To 2024-01-01 

征募观察对象时间:

Recruiting time:

From2022-06-01To 2025-01-01 

干预措施:

Interventions:

组别:

研究组

样本量:

68

Group:

research group

Sample size:

干预措施:

帕博利珠单抗 200mg D1/D22,白蛋白紫杉醇 260mg/m2 D1/22顺铂 100 mg/m2 D1/22

干预措施代码:

Intervention:

pembrolizumab 200mg D1/D22, nab-paclitaxel260mg/m2 D1/22, cisplatin 100 mg/m2 D1/22

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):

中国人民解放军总医院第六医学中心 

单位级别:

三级医院 

Institution
hospital:

The Sixth Medical Center of PLA General Hospital  

Level of the institution:

Tertiary hospital 

测量指标:

Outcomes:

指标中文名:

无复发生存时间

指标类型:

主要指标 

Outcome:

recurrence free survival

Type:

Primary 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:

组织

组织:

肿瘤

Sample Name:

tissue

Tissue:

tumor

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:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

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

No

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

病例记录表

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

CRF

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:

CRF

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

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2022-01-27
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