Trial Title:
FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
NCT ID:
NCT05755048
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Ado-Trastuzumab Emtansine
Maytansine
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502)
Description:
Experimental: FS-1502 Dosage form: lyophilized powder Specification: 30 mg/vial Dose: 2.3
mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous
drip.
Arm group label:
FS-1502
Intervention type:
Biological
Intervention name:
Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)
Description:
Active Comparator: Trastuzumab Emtansine (T-DM1) Trade name: Kadcyla Dosage form:
lyophilized powder Specification: 100 mg/vial Dose: 3.6 mg/kg, once every 3 weeks, 21
days as a cycle; Method of administration: intravenous drip (this drug has been approved
for marketing. Please refer to the package insert for details).
Arm group label:
Trastuzumab Emtansine (T-DM1)
Summary:
This study is designed to compare the anti-tumor activity as well as the safety and
efficacy of FS-1502 versus T-DM1 in HER2-positive, unresectable locally advanced or
metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Detailed description:
This study is a multicenter, open-label, randomized controlled phase III clinical study
to compare the efficacy and safety of FS-1502 versus T-DM1 in patients with HER2-positive
unresectable locally advanced or metastatic breast cancer. Patients who meet the
inclusion and exclusion criteria will be randomized into the test group (FS-1502) or
control group (T-DM1) in a 1:1 ratio. Patients in the test group will receive FS-1502 2.3
mg/kg, and those in the control group will receive T-DM1 3.6 mg/kg, by intravenous drip
every 3 weeks. Patients will be treated until disease progression (PD), intolerable
toxicity, withdrawal of consent, death, or other protocol-specified reasons. According to
the Response Evaluation Criteria in Solid Tumours (RECIST 1.1), tumor assessment will be
performed every 6 weeks (± 7 days) for the first 12 months and every 12 weeks (± 7 days)
after 12 months until PD, withdrawal of consent, or death. Efficacy evaluation will be
performed by the investigator and the Independent Review Committee (IRC), respectively.
Criteria for eligibility:
Criteria:
Inclusion Criteria:Subjects are eligible to be included in the study only if they meet
all of the following criteria:
1. Male or female age ≥ 18;
2. Histologically or cytologically confirmed HER2-positive unresectable locally
advanced or metastatic breast cancer;
3. Prior treatment with trastuzumabs and taxanes in the adjuvant therapy, neoadjuvant
therapy, or advanced treatment phases;
4. ≥ 1 and ≤ 3 previous lines of therapy against locally advanced or metastatic
diseases, if PD occurring during adjuvant therapy/neoadjuvant therapy and within 12
months after treatment can be taken as one line of therapy;
5. Tissue samples qualified by the central laboratory for HER2 detection are available,
and HER2 is confirmed positive by the pathology test in the central laboratory:
Immunohistochemistry (IHC) 3+, or IHC2+ and fluorescence in situ hybridization
(FISH)+ as the basis for inclusion;
6. ECOG score at 0 or 1;
7. Expected survival ≥ 12 weeks;
8. Adequate organ and bone marrow functions: absolute neutrophil count [ANC]
≥1.0×10^9/L (no use of granulocyte-colony-stimulating factor (G-CSF) within 7 days);
hemoglobin (HGB) ≥ 90 g/L (no red blood cell transfusion within 14 days); platelet
count (PLT) ≥ 100×10^9/L (no use of platelet-elevating drugs within 7 days, no
platelet transfusion within 14 days); total serum bilirubin (TSB) ≤ 1.5 × upper
limit of normal (ULN) or ≤ 3.0 × ULN for patients with Gilbert syndrome; aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; for patients
with liver metastases, AST and ALT ≤ 5×ULN; creatinine clearance ≥ 50 mL/min
(calculated by Cockroft-Gault formula); blood potassium ≥3.5 mmol/L; albumin ≥ 3
g/dL; left ventricular ejection fraction (LVEF) >50%; urine protein ≤1+ or 24h urine
protein quantification <1.0 g;
9. At least one non-intracranial evaluable lesion as assessed by RECIST 1.1;
10. Female patients of childbearing potential must agree to take highly effective
contraceptive measures or avoid sexual intercourse during and after the study and
within at least 3 months after the last dose of FS-1502 and within at least 7 months
after the last dose of T-DM1. Male patients must agree to avoid sexual intercourse,
or they and/or any female partners of childbearing potential must take a medically
acceptable and effective contraceptive measure, such as double barrier methods,
condoms, oral or injectable contraceptives, intra-uterine devices during and after
the study and within at least 3 months after the last dose of FS-1502 or within at
least 4 months after the last dose of T-DM1;
11. Be able to understand and voluntarily sign the written Informed Consent Form (ICF).
Exclusion Criteria:
Patients that meet any of the following conditions shall not be included in this clinical
study:
1. Patients who have received chemotherapy, small molecule targeted drug therapy,
endocrinotherapy，radiotherapy, etc. within 14 days or 5 half-lives (whichever is
shorter) before administration or who have received major surgical treatment and
tumor immunotherapy within 4 weeks before administration or who have received large
molecule monoclonal antibody drugs for cancer treatment within 21 days before
administration.
2. Patients who have participated in other clinical studies within 4 weeks or 5
half-lives of the drug (whichever is shorter) before administration.
3. Patients who have been previously treated with anti-HER2 ADCs for metastatic
diseases.
4. Patients with known hypersensitivity or delayed type hypersensitivity to certain
ingredients of T-DM1 or similar drugs, or with known contraindications for the use
of T-DM1.
5. Patients with pia maters, spinal cords, brainstem and brain parenchymal metastases;
such patients are allowed to be enrolled if all of the following conditions are met:
1. Patients who have received local treatment and the lesions are stable for more
than 6 months;
2. Patients who have no clinical symptoms and don't need glucocorticoid therapy or
other dehydration treatment, and have a stable dose of an antiepileptic drug,
if applicable.
6. Patients with a large quantity of clinically uncontrolled pleural effusion,
pericardial effusion, or ascites (within 2 weeks prior to the first dose).
7. Unresolved toxic reactions from previous anti-tumor therapy (> NCI-CTCAE 5.0 Grade
1); however, alopecia, neurotoxicity or other toxicity that has converted to chronic
and returned to NCI-CTCAE 5.0 Grade ≤ 2, and does not affect the safety of the
patient as assessed by the Investigator are allowed to be enrolled.
8. History of non-infectious interstitial lung disease (ILD) / pneumonia, current ILD /
pneumonia, or imaging suggestive of suspected moderate-severe ILD / pneumonia at
screening.
9. Subjects with corneal epithelial lesions (except mild punctate keratopathy), or
other ocular diseases that affect the evaluation of ocular toxicity after the
investigational product administration, or unwilling to stop wearing corneal contact
lenses during the study.
10. Patients on medications that prolong the QTc interval (mainly Classes Ia, Ic, III
anti- arrhythmia medications) or with risk factors for prolonging the QTc interval,
such as uncorrectable hypokalemia, inherited long QT syndrome; potential medications
for prolonging the QTc interval are presented in Appendix 7.
11. Cardiac function and diseases that meet one of the following conditions:
1. Mean QTc > 450 ms for males and mean QTc > 470 ms for females averaged from 3
results of 12-lead ECG measurements using the QTcF formula of the ECG
instrument at the study site during the screening period;
2. New York Heart Association (NYHA) Functional Classification ≥ Class 2
congestive heart failure;
3. Clinically significant arrhythmia (Grade ≥ 2);
4. History of myocardial infarction or severe arteriovenous thrombotic events
within 6 months.
12. Pregnant or breastfeeding women.
13. Known hypersensitivity to any excipients of FS-1502.
14. Active infection requiring systemic therapy.
15. Active hepatitis B (positive for HBV surface antigen and detected with HBV DNA >
1000 IU/mL or meeting the diagnostic criteria for active hepatitis B infection at
the study site) or hepatitis C (positive for HCV RNA) and human immunodeficiency
viral infection (HIV positive).
16. Any other malignancy diagnosed within 5 years prior to the study, except for early
malignancies (carcinoma in situ) that have undergone radical treatment, such as
adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ.
17. Any other diseases or conditions considered clinically significant by the
investigator that could affect protocol compliance or affect the patient's ability
to sign the ICF.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The first affiliated hospital of bengbu medical college
Address:
City:
Bengbu
Country:
China
Status:
Recruiting
Contact:
Last name:
Gongsheng Jin, MD
Phone:
13095520028
Email:
Jgs2007@qq.com
Investigator:
Last name:
Gongsheng Jin, MD
Email:
Principal Investigator
Facility:
Name:
Anhui Provincial Cancer Hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Changlu Hu, MD
Phone:
13955116061
Email:
13955116061@139.com
Investigator:
Last name:
Changlu Hu, MD
Email:
Principal Investigator
Facility:
Name:
Chinese People's Liberation Army General Hospital fifth Medical Center South ward
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Wang, MD
Phone:
13910928773
Email:
wangtaodoc@163.com
Investigator:
Last name:
Tao Wang, MD
Email:
Principal Investigator
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Shu Wang, MD
Phone:
13801080201
Email:
dr.wangshu@263.net
Investigator:
Last name:
Shu Wang, MD
Email:
Principal Investigator
Facility:
Name:
Affiliated Cancer Hospital of Chongqing University
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xin Zhou, MD
Phone:
13452987363
Email:
zhouxin000017@163.com
Investigator:
Last name:
Xin Zhou, MD
Email:
Principal Investigator
Facility:
Name:
Chinese People's Liberation Army Army Special Medical Center
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinlu Shan, MD
Phone:
18623026302
Email:
lulu@sina.com
Investigator:
Last name:
Jinlu Shan, MD
Email:
Principal Investigator
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
YueHua Wang, MD
Phone:
13995777482
Email:
510839835@qq.com
Investigator:
Last name:
YueHua Wang, MD
Email:
Principal Investigator
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoyan Lin, MD
Phone:
139 5048 2366
Email:
13950482366@qq.com
Investigator:
Last name:
Xiaoyan Lin, MD
Email:
Principal Investigator
Facility:
Name:
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xi Chen, MD
Phone:
13705045925
Email:
cxifuzhou@163.com
Investigator:
Last name:
Xi Chen, MD
Email:
Principal Investigator
Facility:
Name:
The first affiliated hospital of xiamen university
Address:
City:
Xiamen
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhong Ouyang, doctor
Phone:
18205962909
Email:
xmdxdyyyrxkoyz@163.com
Investigator:
Last name:
Zhong Ouyang, doctor
Email:
Principal Investigator
Facility:
Name:
The first Hospital of lanzhou University
Address:
City:
Lanzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoling Ling, MD
Phone:
18693165668
Email:
lingxiaolingedu@163.com
Investigator:
Last name:
Xiaoling Ling, MD
Email:
Principal Investigator
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Kun Wang, MD
Phone:
13922118086
Email:
gzwangkun@126.com
Investigator:
Last name:
Kun Wang, MD
Email:
Principal Investigator
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanxia Shi, MD
Phone:
13609058827
Email:
shiyx@sysucc.org.cn
Investigator:
Last name:
Yanxia Shi, MD
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital,Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Lin, MD
Phone:
130 7687 3871
Email:
frostlin@hotmail.com
Investigator:
Last name:
Ying Lin, MD
Email:
Principal Investigator
Facility:
Name:
Shantou University School of Medicine Affiliated Cancer Hospital
Address:
City:
Shantou
Country:
China
Status:
Recruiting
Contact:
Last name:
De Zeng, MD
Phone:
13750418885
Email:
alexzengde@163.com
Investigator:
Last name:
De Zeng, MD
Email:
Principal Investigator
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
Address:
City:
Shenzhen
Country:
China
Status:
Recruiting
Contact:
Last name:
Caiwen Du, MD
Phone:
135 5631 6023
Email:
dusumc@aliyun.com
Investigator:
Last name:
Caiwen Du, MD
Email:
Principal Investigator
Facility:
Name:
Guangxi Medical Univesity Cancer Hospital
Address:
City:
Nanning
Country:
China
Status:
Recruiting
Contact:
Last name:
Weimin Xie, MD
Phone:
13907861028
Email:
dd.xie@qq.com
Investigator:
Last name:
Weimin Xie, MD
Email:
Principal Investigator
Facility:
Name:
The First Afeliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Country:
China
Status:
Recruiting
Contact:
Last name:
Jincai Zhong, M.M.
Phone:
13907719863
Email:
1093301007@qq.com
Investigator:
Last name:
Jincai Zhong, M.M.
Email:
Principal Investigator
Facility:
Name:
Affiliated Hospital of Hebei University
Address:
City:
Baoding
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Yang, MD
Phone:
18603120729
Email:
docyh@163.com
Investigator:
Last name:
Hua Yang, MD
Email:
Principal Investigator
Facility:
Name:
Cangzhou Central Hospital
Address:
City:
Cangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Guozhong Cui, MD
Phone:
13315777876
Email:
916291826@qq.com
Investigator:
Last name:
Guozhong Cui, MD
Email:
Principal Investigator
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Country:
China
Status:
Recruiting
Contact:
Last name:
Yunjiang Liu, doctor
Phone:
13703297890
Email:
lyj818326@126.com
Investigator:
Last name:
Yunjiang Liu, doctor
Email:
Principal Investigator
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Country:
China
Status:
Recruiting
Contact:
Last name:
Qing Yuan Zhang, MD
Phone:
13313612989
Email:
ns86298333@163.com
Investigator:
Last name:
Qing Yuan Zhang, MD
Email:
Principal Investigator
Facility:
Name:
AnYang Cancer Hospital
Address:
City:
AnYang
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Xia, MD
Phone:
15890750990
Email:
15890750990@126.com
Investigator:
Last name:
Jin Xia, MD
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Xinxiang Medical University
Address:
City:
Xinxiang
Country:
China
Status:
Recruiting
Contact:
Last name:
Ping Lu, MD
Phone:
18567569821
Email:
lupingdoctor@126.com
Investigator:
Last name:
Ping Lu, MD
Email:
Principal Investigator
Facility:
Name:
Henan Provincial People's Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Chuangxin Lu, MD
Phone:
15093406297
Email:
lcxin618@163.com
Investigator:
Last name:
Chuangxin Lu, MD
Email:
Principal Investigator
Facility:
Name:
Renmin Hospital Of Wuhan University
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Yao, MD
Phone:
13667174996
Email:
yaofengrmh@163.com
Investigator:
Last name:
Feng Yao, MD
Email:
Principal Investigator
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
yanxia Zhao, MD
Phone:
13407192551
Email:
sophia7781@126.com
Investigator:
Last name:
yanxia Zhao, MD
Email:
Principal Investigator
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
HaiJun Yu, MD
Phone:
13971665181
Email:
doctoryhj@126.com
Investigator:
Last name:
HaiJun Yu, MD
Email:
Principal Investigator
Facility:
Name:
Xiangyang Central Hospital
Address:
City:
Xiangyang
Country:
China
Status:
Recruiting
Contact:
Last name:
WeiWei Huang, MD
Phone:
13763893896
Email:
huangstudenth@163.com
Investigator:
Last name:
WeiWei Huang, MD
Email:
Principal Investigator
Facility:
Name:
The Second Xiangya Hospital, Central South University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenjun Yi, Doctor
Phone:
18608403318
Email:
yiwenjun@csu.edu.cn
Investigator:
Last name:
Wenjun Yi, Doctor
Email:
Principal Investigator
Facility:
Name:
Chenzhou No.1 People's Hospital
Address:
City:
Chenzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Hailong Liu, MD
Phone:
18973575117
Email:
827362121@qq.com
Investigator:
Last name:
Hailong Liu, MD
Email:
Principal Investigator
Facility:
Name:
The Central Hospital of Yongzhou
Address:
City:
Yongzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Sijuan Ding, MM
Phone:
13574624257
Email:
874663807@qq.com
Investigator:
Last name:
Sijuan Ding, MM
Email:
Principal Investigator
Facility:
Name:
Jiangsu Cancer Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jifeng Feng, MD
Phone:
13901581264
Email:
fjif@vip.sina.com
Investigator:
Last name:
Jifeng Feng, MD
Email:
Principal Investigator
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongmei Yin, MD
Phone:
13951842727
Email:
ym.yin@hotmail.com
Investigator:
Last name:
Yongmei Yin, MD
Email:
Principal Investigator
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Tian You Tang, MB
Phone:
13775980765
Email:
tty912@163.com
Investigator:
Last name:
Tian You Tang, MB
Email:
Principal Investigator
Facility:
Name:
Nanchang People's Hospital
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenyan Chen, MB
Phone:
18679168977
Email:
chenwenyannc2013@163.com
Investigator:
Last name:
Wenyan Chen, MB
Email:
Principal Investigator
Facility:
Name:
First Hospital of Jilin University
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiuwei Cui, MD
Phone:
15843073215
Email:
jdyycjw@163.com
Investigator:
Last name:
Jiuwei Cui, MD
Email:
Principal Investigator
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Cheng, MD
Phone:
0431-80596315
Email:
jl.cheng@163.com
Investigator:
Last name:
Ying Cheng, MD
Email:
Principal Investigator
Facility:
Name:
The Second Affiliated Hospital of Dalian Medical University
Address:
City:
Dalian
Country:
China
Status:
Recruiting
Contact:
Last name:
Ma Li, MD
Phone:
17709873580
Email:
dyeyliman@sohu.com
Investigator:
Last name:
Ma Li, MD
Email:
Principal Investigator
Facility:
Name:
Liaoning cancer hospital & institute
Address:
City:
Shenyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Tao Sun, MD
Phone:
13940404526
Email:
lnzlrxnsy@163.com
Investigator:
Last name:
Tao Sun, MD
Email:
Principal Investigator
Facility:
Name:
The first hospital of china medical university
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuee Teng, MD
Phone:
13591639797
Email:
tengyuee0517@163.com
Investigator:
Last name:
Yuee Teng, MD
Email:
Principal Investigator
Facility:
Name:
General Hospital of Ningxia Medical University
Address:
City:
Yinchuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinlan Liu, MD
Phone:
13709577339
Email:
liuxinlan@csco.ac.cn
Investigator:
Last name:
Xinlan Liu, MD
Email:
Principal Investigator
Facility:
Name:
Shandong First Medical University and Shandong Academy of Medical Sciences Shandong Cancer Hospital institute
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Huihui Li, MD
Phone:
15553103209
Email:
15553103209@163.com
Investigator:
Last name:
Huihui Li, MD
Email:
Principal Investigator
Facility:
Name:
Affiliated Hospital of Jining Medical University
Address:
City:
Jining
Country:
China
Status:
Recruiting
Contact:
Last name:
Changping Shan, MD
Phone:
18678766865
Email:
scp9933@163.com
Investigator:
Last name:
Changping Shan, MD
Email:
Principal Investigator
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingfen Wang, MD
Phone:
15963976026
Email:
15963976026@wetrial.com
Investigator:
Last name:
Jingfen Wang, MD
Email:
Principal Investigator
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Fuguo Tian, MD
Phone:
13934559988
Email:
2205473988@qq.com
Investigator:
Last name:
Fuguo Tian, MD
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xian
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Yang, MD
Phone:
18991232383
Email:
1473106133@qq.com
Investigator:
Last name:
Jin Yang, MD
Email:
Principal Investigator
Facility:
Name:
West China Hospital，Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
YanHui Liu, MD
Phone:
18980601509
Email:
827005432@qq.com
Investigator:
Last name:
YanHui Liu, MD
Email:
Principal Investigator
Facility:
Name:
Affiliated Hospital of Southwest Medical University
Address:
City:
Luzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Lijia He, MD
Phone:
13619042857
Email:
908380148@qq.com
Investigator:
Last name:
Lijia He, MD
Email:
Principal Investigator
Facility:
Name:
Neijiang Second People's Hospital
Address:
City:
Neijiang
Country:
China
Status:
Recruiting
Contact:
Last name:
Xujuan Wang, MD
Phone:
13696038558
Email:
61132803@qq.com
Investigator:
Last name:
Xujuan Wang, MD
Email:
Principal Investigator
Facility:
Name:
TianJin Medical university Cancer Institute & Hospital
Address:
City:
TianJin
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhongsheng Tong, MD
Phone:
18622221181
Email:
18622221181@163.COM
Investigator:
Last name:
Zhongsheng Tong, MD
Email:
Principal Investigator
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianyun Nie, MD
Phone:
13608815577
Email:
niejianyungcp@163.com
Investigator:
Last name:
Jianyun Nie, MD
Email:
Principal Investigator
Facility:
Name:
The Second Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Huang, MD
Phone:
139 5812 3068
Email:
hjys@zju.edu.cn
Investigator:
Last name:
Jian Huang, MD
Email:
Principal Investigator
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojia Wang, MD
Phone:
13906500190
Email:
wxiaojia0803@163.com
Investigator:
Last name:
Xiaojia Wang, MD
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
OuChen Wang, MD
Phone:
13957706099
Email:
woc099@163.com
Investigator:
Last name:
OuChen Wang, MD
Email:
Principal Investigator
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Min Yan, dotocr
Phone:
15713857388
Email:
ym200678@126.com
Investigator:
Last name:
Min Yan, dotocr
Email:
Principal Investigator
Start date:
March 28, 2023
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Agency class:
Industry
Source:
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755048
