中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400091331
最近更新日期： Date of Last Refreshed on：	2024-10-25 17:24:46
注册时间： Date of Registration：	2024-10-25 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	伊马替尼联合白蛋白紫杉醇、吉西他滨用于晚期胰腺导管腺癌的临床研究
Public title：	Imatinib combined with albumin paclitaxel, gemcitabine for clinical studies in advanced pancreatic ductal adenocarcinoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	伊马替尼联合白蛋白紫杉醇、吉西他滨用于晚期胰腺导管腺癌的临床研究
Scientific title：	Imatinib combined with albumin paclitaxel, gemcitabine for clinical studies in advanced pancreatic ductal adenocarcinoma
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：	许琼聪	研究负责人：	殷晓煜
Applicant：	Qiongcong Xu	Study leader：	Xiaoyu Yin
申请注册联系人电话： Applicant telephone：	+86 159 0205 5141	研究负责人电话： Study leader's telephone：	+86 139 0229 0933
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：	xuqc5@mail.sysu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	yinxy@mail.sysu.edu.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：	广东省广州市中山二路58号	研究负责人通讯地址：	广东省广州市中山二路58号
Applicant address：	No.58 Zhongshan 2nd Road, Guangzhou, Guangdong	Study leader's address：	No.58 Zhongshan 2nd Road, Guangzhou, Guangdong
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：	中山大学附属第一医院
Applicant's institution：	The First Affiliated Hospital of Sun Yat-Sen University
研究负责人所在单位：	中山大学附属第一医院
Affiliation of the Leader：	The First Affiliated Hospital of Sun Yat-Sen University

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：	伦审临[2023]628 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：	中山大学附属第一医院临床科研和实验动物伦理委员会
Name of the ethic committee：	IEC for Clinical Research and Animal Trials of the First Affiliated Hospital of Sun Yat-sen University
伦理委员会批准日期： Date of approved by ethic committee：	2023-11-03 00:00:00
伦理委员会联系人：	颜楚荣
Contact Name of the ethic committee：	Churong Yan
伦理委员会联系地址：	广东省广州市中山二路58号
Contact Address of the ethic committee：	No.58 Zhongshan 2nd Road, Guangzhou, Guangdong
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 20 8733 4871	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：

中山大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Sun Yat-Sen University

研究实施负责（组长）单位地址：

广东省广州市中山二路58号

Primary sponsor's address：

No.58 Zhongshan 2nd Road, Guangzhou, Guangdong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	广东	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	中山大学附属第一医院	具体地址：	广东省广州市中山二路58号
Institution hospital：	The First Affiliated Hospital of Sun Yat-Sen University	Address：	No.58 Zhongshan 2nd Road, Guangzhou, Guangdong

经费或物资来源：

中山大学附属第一医院

Source(s) of funding：

The First Affiliated Hospital of Sun Yat-Sen University

研究疾病：

晚期胰腺导管腺癌

Target disease：

advanced pancreatic ductal adenocarcinoma

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：

I期临床试验

Study phase：

1

研究设计：

单臂

Study design：

Single arm

研究目的：

主要目的：  以ORR为指标，观察和评价伊马替尼联合白蛋白紫杉醇、吉西他滨用于晚期胰腺导管腺癌的有效性。次要目的：  以AEs为指标，观察和评价伊马替尼联合白蛋白紫杉醇、吉西他滨用于晚期胰腺导管腺癌的安全性。

Objectives of Study：

Primary Objectives:  To observe and evaluate the effectiveness of imatinib combined with albumin paclitaxel and gemcitabine in the treatment of advanced pancreatic ductal adenocarcinoma using ORR as an index. Secondary Purpose:  To observe and evaluate the safety of imatinib combined with albumin paclitaxel and gemcitabine in the treatment of advanced pancreatic ductal adenocarcinoma using ORR as an index.

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

Patients who meet the following criteria will be included in this study and will use imatinib in combination with albumin paclitaxel, gemcitabine regimen:
1. Age 18-80 years old, male or female;
2. Patients with untreated pancreatic ductal adenocarcinoma (PDAC) confirmed by pathological examination; or untreated recurrent pancreatic ductal adenocarcinoma (surgery, adjuvant/neoadjuvant chemotherapy was allowed in the past, and it was ≥3 months after the end of adjuvant chemotherapy at the time of recurrence, and the adjuvant/neoadjuvant chemotherapy regimen did not include imatinib, gemcitabine, and nab-paclitaxel);
3. Physical condition ECOG PS score: 0-1 points;
4. Estimated survival ≥ 3 months;
5. At least 1 measurable target lesion that can be examined by CT or MRI according to RECIST 1.1 criteria;
6. The laboratory examination indicators meet the following requirements:
(1) Bone marrow function: hemoglobin (Hb) ≥90g/L; White blood cell count (WBC) ≥ lower limit of normal; Absolute neutrophil value (ANC) ≥1.5×10^9 /L; Platelet count ≥ 100×10^9/L;
(2) Renal function: Cr≤UNL (upper limit of normal) ×1.5, endogenous creatinine clearance (Ccr) ≥55 ml/min;
(3) Liver function: total bilirubin ≤ULN×1.5;ALT and AST≤ULN×2.5;(if there is liver metastasis, total bilirubin is not higher than 3 times the upper limit of normal, and transaminases are not higher than 5 times the upper limit of normal);
(4) Coagulation function: the international normalized ratio of prothrombin time ≤ULN×1.5, and some thromboplastin time was within the normal range;
7. Have not received any prior anti-tumor therapy for advanced PDAC, including chemotherapy, radiotherapy, targeted, hormonal or immunological therapy; Patients after R2 resection are allowed to enroll;
8. Females of childbearing potential agree to use contraception during the study and for 6 months after the end of the study; Patients with a negative serum or urine pregnancy test within seven days prior to study enrollment and who are not lactating; Patients whose males agree to use contraception during the study and for 6 months after the end of the study;
9. Those who have not participated in other drug clinical trials within 4 weeks before enrollment;
10. Subjects can understand the situation of this study and voluntarily sign the informed consent form.
11. No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever >38°C;
12. It is expected that those with good compliance can follow up the efficacy and adverse reactions according to the requirements of the protocol.

排除标准：

具有以下任何一项的患者不纳入本研究采集数据: 1. 既往5年内已诊断其它恶性肿瘤，尤其是慢性粒细胞白血病、胃肠道间质瘤（原位癌、基底细胞癌等除外）； 2. 已知有中枢神经系统转移者（经放疗或手术 4 周后疾病控制稳定且无症状者除外）或癌性脑膜炎证据者； 3. 患有精神或神经系统疾患，不能配合者； 4. 既往接受过本研究用药方案（伊马替尼、白蛋白结合型紫杉醇、吉西他滨）的患者； 5. 准备进行或既往接受过器官或骨髓移植的患者； 6. 患有任何活动性自身免疫病或自身免疫病史； 7. 首次给药前30天内接种过活疫苗（允许使用注射型季节性流感疫苗，因该疫苗为灭活疫苗）； 8. 患有未能控制的心脏临床症状或疾病； 9. 有活动性感染或发热（明确的肿瘤热除外）； 10. 间质性肺病或活动性非感染性肺炎病史或证据； 11. 患其他疾病不适合入组者，如免疫功能缺陷、活动性肺结核、乙肝（经治疗后乙肝病毒滴度HBV-DNA<500IU/ml，且肝功能正常则可入组）、丙肝病毒检测阳性、无法纠正的电解质紊乱、不可控制的心包积液、胸腔积液及腹腔积液等； 12. 对本方案中任何药物过敏者； 13. 入组前14天内使用免疫抑制药物或皮质类固醇>10mg/天泼尼松疗效剂量者； 14. 入组前4周内接受过放疗、化疗、靶向治疗或免疫治疗者； 15. 妊娠期或哺乳期妇女； 16. 研究者认为不适合入组者。

Exclusion criteria：

Patients with any of the following are not included in the data collected in this study: 1. Other malignant tumors have been diagnosed within the past 5 years, especially chronic myeloid leukemia and gastrointestinal stromal tumors (except carcinoma in situ, basal cell carcinoma, etc.); 2. Known central nervous system metastases (except for those with stable disease control and asymptomatic after 4 weeks of radiotherapy or surgery) or evidence of carcinomatous meningitis; 3. Those who suffer from mental or neurological diseases and are unable to cooperate; 4. Patients who have previously received the drug regimen of this study (imatinib, albumin paclitaxel, gemcitabine); 5. Patients who are ready to undergo or have previously received organ or bone marrow transplantation; 6. Has any active autoimmune disease or history of autoimmune disease; 7. Vaccination with a live vaccine within 30 days prior to the first dose (injectable seasonal influenza vaccine is allowed as the vaccine is an inactivated vaccine); 8. Have uncontrolled cardiac clinical symptoms or diseases; 9. Have active infection or fever (except for definite tumor fever); 10. History or evidence of interstitial lung disease or active non-infectious pneumonitis; 11. Those with other diseases who are not suitable for enrollment, such as immunodeficiency, active tuberculosis, hepatitis B (hepatitis B virus titer HBV-DNA <500IU/ml after treatment, and normal liver function can be enrolled), positive hepatitis C virus test, uncorrectable electrolyte imbalance, uncontrollable pericardial effusion, pleural effusion and ascites effusion, etc.; 12. Those who are allergic to any of the drugs in this regimen; 13. Those who have used immunosuppressive drugs or corticosteroids within 14 days before enrollment> 10mg/day prednisone efficacy dose; 14. Those who have received radiotherapy, chemotherapy, targeted therapy or immunotherapy within 4 weeks before enrollment; 15. Pregnant or lactating women; 16. Those who are considered unsuitable for enrollment by the investigator.

研究实施时间：

Study execute time：

从 From 2024-11-01 00:00:00至 To 2026-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-11-01 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	62
Group：	Experimental group	Sample size：	62
干预措施：	伊马替尼联合白蛋白紫杉醇、吉西他滨方案	干预措施代码：
Intervention：	Imatinib combined with albumin paclitaxel, gemcitabine	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	中山大学附属第一医院	单位级别：	三甲
Institution hospital：	The First Affiliated Hospital of Sun Yat-Sen University	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：	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：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	病理穿刺组织	组织：
Sample Name：	Pathological puncture tissue	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：

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	80	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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
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）：	在试验完成后的6个月内，通过临床试验公共管理平台共享原始数据（http://www.medresman.org.cn）。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Within 6 months after the completion of the trial, the metadata will be shared through the clinical trial management public platform (http://www.medresman.org.cn).
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：	数据采集使用病例记录表（CRF）采集。数据管理使用临床试验公共管理平台（http://www.medresman.org.cn）。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection was performed by using the case record form (CRF). The data management was performed by using the clinical trial management public platform (http://www.medresman.org.cn).
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：	2024-10-25 17:24:21