Trial Title:
Anlotinib Hydrochloride Capsules Combined With TQB2450 in the Treatment of Endometrial Cancer
NCT ID:
NCT06475599
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Anlotinib hydrochloride capsule + TQB2450 injection
Description:
Anlotinib hydrochloride capsule is a multi-target tyrosine kinase inhibitor, which
targets VEGFR (VEGFR-1, VEGFR-2 and VEGFR-3), PDGFR, FGFR and c-Kit, etc. It can inhibit
tumor progression by inhibiting angiogenesis and tumor growth at the same time.
TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand 1
(PD-L1) that prevents the binding of PD-L1 to the PD-1 and B7.1 receptors on the T-cell
surface, allowing T-cell reactivation and thus enhancing the immune response.
Arm group label:
Anlotinib hydrochloride capsules + TQB2450 injection
Intervention type:
Drug
Intervention name:
Chemotherapy drug
Description:
Based on each patient's condition and previous treatment history, the investigator will
select one of the chemotherapy drugs (including Paclitaxel, Albumin, Doxorubicin and
Doxorubicin hydrochloride) for treatment.
Arm group label:
Chemotherapy drug
Summary:
To demonstrate that anlotinib hydrochloride capsules combined with TQB2450 injection can
significantly prolong progression-free survival (PFS) compared with chemotherapy in
patients with recurrent or metastatic endometrial cancer that is non- microsatellite
instability high (non-MSI-H) or DNA mismatch repair deficient (non-dMMR).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Recurrent or metastatic advanced endometrial cancer confirmed by histopathology;
- Patients failed to respond to 1-2 lines of platinum-based doublet-based therapy;
- Provide a traceable MMR/MSI status report or provide biological samples for DNA
mismatch repair/microsatellite instability (MMR/MSI) status testing with
non-MSI-high (non-MSI-H) or non-dMMR；
- Patients who cannot undergo radical surgery/radiotherapy;
- Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology
Group (ECOG) performance status (PS) score: 0-1; The expected survival time is more
than 3 months；
- At least one measurable lesion (RECIST 1.1);
- Good function of the major organs；
- Women of childbearing age should agree that they must use a contraceptive method
(e.g. Intra-uterine device (IUD), contraceptive pill, or condom) during the study
and for 6 months after the study; A negative serum pregnancy test within 7 days
before study entry and must be non-lactating；
- Subjects voluntarily joined this study, signed informed consent, and had good
compliance；
Exclusion Criteria:
- Previous use of bevacizumab, endostar, anlotinib, apatinib, lenvatinib, sorafenib,
sunitinib, regorafenib, fruquintinib and other anti-angiogenic drugs or
immunotherapy drugs targeting programmed cell death protein 1 (PD-1), PD-L1 and
other related cells；
- Patients received anti-tumor indications of Chinese patent medicine approved by
National Medical Products Administration (NMPA) within 2 weeks before the study
treatment；
- Pathology suggested carcinosarcoma (malignant mullerian mixed tumor), endometrial
leiomyosarcoma or other high-grade sarcoma, or endometrial stromal sarcoma；
- Hormone therapy for endometrial cancer had been received within 1 week before the
first dose of trial medication；
- Surgery, chemotherapy, radiation therapy, or other anticancer therapy had been
received within 4 weeks before the initiation of study treatment (the washout period
was calculated from the end of the last treatment). The half-life of oral targeted
drugs was less than 5 drugs；
- Subjects with known central nervous system metastases and/or carcinomatous
meningitis; The patients were not asymptomatic or were treated and stable, had no
radiographic evidence of new or expanding brain metastases for at least 2 weeks
after treatment for brain metastases, and had discontinued steroids or
anticonvulsant therapy for at least 14 days before the initiation of study
treatment；
- The patient had developed or had concurrent malignant tumors within the past 3
years；
- Multiple factors that affect the oral administration of anlotinib (e.g., inability
to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal
obstruction) may affect the oral absorption of anlotinib；
- Uncontrolled pleural, pericardial, or ascites requiring repeated drainage
(investigator judgment); Severe bone injury caused by tumor bone metastasis may
occur or occur after enrollment；
- Patients whose imaging (CT or MRI) showed that the tumor had invaded the important
blood vessels or the investigators judged that the tumor was likely to invade the
important blood vessels and cause fatal hemorrhage during the follow-up study；
- Unmitigated toxic effects higher than CTCAE grade 1 due to any previous
antineoplastic therapy, excluding alopecia；
- Major surgical treatment, open biopsy, or significant traumatic injury within 28
days before the first dose；
- A wound or fracture that has not healed for a long time；
- Patients with a history of arterial/venous thrombosis/cancer thrombosis within 6
months before the first dose of drug, such as cerebrovascular accident (including
transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein
thrombosis and pulmonary embolism；
- People who have a history of psychotropic drug abuse and cannot abstain from it or
have mental disorders；
- Subjects with any severe and/or uncontrolled illness；
- A history of vaccination with live attenuated vaccine within 28 days before the
initiation of study treatment or a planned vaccination with live attenuated vaccine
during the study；
- Patients with severe allergic disease, history of severe drug allergy, and known
allergic to any component of the trial drug prescription;；
- Active autoimmune disease requiring systemic therapy (e.g., disease-modifying
agents, corticosteroids, or immunosuppressive agents) had developed within 2 years
before the initiation of study treatment；
- Patients who are diagnosed with immunodeficiency or who are receiving systemic
glucocorticoid therapy or any other form of immunosuppressive therapy (at a dose of
>10mg/ day of prednisone or other equivalent efficacy hormone) and continue to do so
within 2 weeks before the first dose; Major surgical treatment or significant
traumatic injury within 4 weeks before the first dose in this study；
- Participated in other clinical trials of antineoplastic drugs within 4 weeks before
the first dose；
- Subjects with concomitant diseases that seriously endanger the safety of the
subjects or interfere with the completion of the study, or those who were considered
to be unsuitable for enrollment for other reasons according to the investigator's
judgment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230001
Country:
China
Contact:
Last name:
Ying Zhou, Doctor
Phone:
13865901025
Email:
13865901025@139.com
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Contact:
Last name:
Yang Sun, Doctor
Phone:
15959028989
Email:
doctorsunyang@sina.com
Facility:
Name:
First Hospital of Lanzhou University
Address:
City:
Lanzhou
Zip:
730000
Country:
China
Contact:
Last name:
Chang Liu, Doctor
Phone:
13893479248
Email:
44025660@qq.com
Facility:
Name:
Gansu Provincial Cancer Hospital
Address:
City:
Lanzhou
Zip:
730050
Country:
China
Contact:
Last name:
Qingming Zhang, Bachelor
Phone:
13321339133
Email:
1043536297@qq.com
Facility:
Name:
Sun Yat-sen Memorial Hospital
Address:
City:
Guangzhou
Zip:
510289
Country:
China
Contact:
Last name:
Bingzhong Zhang, Doctor
Phone:
13925063030
Email:
13925063030@163.com
Facility:
Name:
The First Affiliated Hospital of Jinan University
Address:
City:
Guangzhou
Zip:
510630
Country:
China
Contact:
Last name:
Yuan Shen, Doctor
Phone:
18102606438
Email:
missyy@126.com
Facility:
Name:
Huizhou Central People's Hospital
Address:
City:
Huizhou
Zip:
516008
Country:
China
Contact:
Last name:
Hailin Xiong, Doctor
Phone:
15976198371
Email:
Xiong0752@hotmail.com
Facility:
Name:
Jiangmen Central Hospital
Address:
City:
Jiangmen
Zip:
529030
Country:
China
Contact:
Last name:
Xiaohong Ruan, Doctor
Phone:
139 2468 0902
Email:
ruanxiaohong@jmszxyy.com.cn
Facility:
Name:
Meizhou People's Hospital
Address:
City:
Meizhou
Zip:
514031
Country:
China
Contact:
Last name:
Jingna Wu, Bachelor
Phone:
13431819838
Email:
wujingna@mzrmyy.com
Facility:
Name:
Guigang City People's Hospital
Address:
City:
Guigang
Zip:
537100
Country:
China
Contact:
Last name:
Yan Wei, Bachelor
Phone:
13321686622
Email:
wyan184@163.com
Facility:
Name:
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Address:
City:
Guilin
Zip:
541000
Country:
China
Contact:
Last name:
Yufei Pan, Master
Phone:
13737740520
Email:
23865934@qq.com
Facility:
Name:
Liuzhou People's Hospital
Address:
City:
Liuzhou
Zip:
545006
Country:
China
Contact:
Last name:
Chanjuan He, Master
Phone:
18077226717
Email:
114457843@qq.com
Facility:
Name:
Liuzhou Municipal Liutie Central Hospital
Address:
City:
Liuzhou
Zip:
545007
Country:
China
Contact:
Last name:
Guiping Lai, Bachelor
Phone:
13768875556
Email:
562795946@qq.com
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530021
Country:
China
Contact:
Last name:
Qingjie Zhang, Doctor
Phone:
15278015900
Email:
1583825050@qq.com
Facility:
Name:
Hainan Ceneral Hospital
Address:
City:
Haikou
Zip:
570311
Country:
China
Contact:
Last name:
Genhai Zhu, Doctor
Phone:
13876082272
Email:
genhaizhu@163.com
Facility:
Name:
Tangshan People's Hospital
Address:
City:
Tangshan
Zip:
063000
Country:
China
Contact:
Last name:
Ping Wang, Doctor
Phone:
18931505881
Email:
wangshjzh@163.com
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Contact:
Last name:
Yunyan Zhang, Postdoctor
Phone:
13604843878
Email:
zhangyunyan-1972@163.com
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
450018
Country:
China
Contact:
Last name:
Xinshuai Wang, Doctor
Phone:
13837986128
Email:
xshuaiw@126.com
Facility:
Name:
Nanyang first People's Hospital National Third Class A Hospital
Address:
City:
Nanyang
Zip:
473000
Country:
China
Contact:
Last name:
Zhen Zhang, Master
Phone:
13663997000
Email:
zhangzhen1771@163.com
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Contact:
Last name:
Liping Han, Doctor
Phone:
13619845906
Email:
hanliping0825@163.com
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Contact:
Last name:
Huifeng Zhang, Master
Phone:
13871012421
Email:
Zhf20081217@126.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Contact:
Last name:
Keqiang Zhang, Doctor
Phone:
13054196067
Email:
zhangkeqiang@hnca.org.cn
Facility:
Name:
The Central Hospital Of Shaoyang
Address:
City:
Shaoyang
Zip:
422000
Country:
China
Contact:
Last name:
Xinfu Liu, Doctor
Phone:
15807397520
Email:
4194478@qq.com
Facility:
Name:
Inner Mongolia Autonomous Region People's Hospital
Address:
City:
Hohhot
Zip:
010017
Country:
China
Contact:
Last name:
Liying Xue, Master
Phone:
18047192517
Email:
xuelyup@126.com
Facility:
Name:
Changchun Tumor Hospital
Address:
City:
Changchun
Zip:
130012
Country:
China
Contact:
Last name:
Yigai Ma, Bachelor
Phone:
13910286029
Email:
18686660731@163.com
Facility:
Name:
The first hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Contact:
Last name:
Ziling Liu, Doctor
Phone:
13943001600
Email:
drzilingliu@163.com
Facility:
Name:
Liaoning Cancer Hospital
Address:
City:
Shenyang
Zip:
110000
Country:
China
Contact:
Last name:
Danbo Wang, Doctor
Phone:
18940251157
Email:
danbo_wang@126.com
Facility:
Name:
Shengjing Hospital Of China Medical University
Address:
City:
Shenyang
Zip:
110000
Country:
China
Contact:
Last name:
Song Gao, Doctor
Phone:
18940251511
Email:
gaos@sj-hospital.org
Facility:
Name:
General Hospital Of Ningxia Medical University
Address:
City:
Yinchuan
Zip:
750001
Country:
China
Contact:
Last name:
Yunxia Li, Bachelor
Phone:
13895071809
Email:
lyx1170@163.com
Facility:
Name:
Qinghai Red Cross Hospital
Address:
City:
Xining
Zip:
810000
Country:
China
Contact:
Last name:
Kuan Zhang, Bachelor
Phone:
18997081048
Email:
875424616@qq.com
Facility:
Name:
The Second Affiliated Hospital of Air Force Medical University
Address:
City:
Xi'an
Zip:
710038
Country:
China
Contact:
Last name:
Haichuan Su, Doctor
Phone:
18629190366
Email:
cntdgcp@163.com
Facility:
Name:
The First Affiliated Hospital of Xi 'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Contact:
Last name:
Ruifang An, Doctor
Phone:
189991232090
Email:
anruifang@163.com
Facility:
Name:
Shaanxi Provincial People's Hospital
Address:
City:
Xi'an
Zip:
712038
Country:
China
Contact:
Last name:
Lihong Chen, Doctor
Phone:
13689280015
Email:
lihongchen29@163.com
Facility:
Name:
Binzhou Medical University Hospital
Address:
City:
Binzhou
Zip:
256600
Country:
China
Contact:
Last name:
Fangling Ning, Master
Phone:
15254311599
Email:
ningfangling@126.com
Facility:
Name:
Binzhou People's Hospital
Address:
City:
Binzhou
Zip:
256601
Country:
China
Contact:
Last name:
Huanlian Yang, Master
Phone:
13854358141
Email:
13854358141@163.com
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Contact:
Last name:
Hao Yu, Doctor
Phone:
15953105039
Email:
fishdoctor@yeah.net
Facility:
Name:
Affiliated Hospital of Jining Medical University
Address:
City:
Jining
Zip:
272001
Country:
China
Contact:
Last name:
Xiaowei Liu, Bachelor
Phone:
18678766867
Email:
jnfylxw@163.com
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Zip:
276000
Country:
China
Contact:
Last name:
Xiumin Li, Master
Phone:
13583991399
Email:
Lyzlyylxm@163.com
Facility:
Name:
Weifang People's Hospital
Address:
City:
Weifang
Zip:
261000
Country:
China
Contact:
Last name:
Guohua Yu, Bachelor
Phone:
13793699977
Email:
ghyry@126.com
Facility:
Name:
Yidu Central Hospital Of Weifang
Address:
City:
Weifang
Zip:
262500
Country:
China
Contact:
Last name:
Peng Wang, Doctor
Phone:
13562677025
Email:
wangpeng1920@sohu.com
Facility:
Name:
Yantai Yuhuangding Hospital
Address:
City:
Yantai
Zip:
264000
Country:
China
Contact:
Last name:
Ying Yang, Doctor
Phone:
15966506506
Email:
hxdany2004@126.com
Facility:
Name:
Tengzhou Central People's Hospital
Address:
City:
Zaozhuang
Zip:
277500
Country:
China
Contact:
Last name:
Kaixian Zhang, Bachelor
Phone:
13563200960
Email:
tengzhouzkx@126.com
Facility:
Name:
Shanxi Cancer hospital
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Contact:
Last name:
Hongwei Zhao, Doctor
Phone:
13633412660
Email:
inmind20060829@126.com
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Zip:
30000
Country:
China
Contact:
Last name:
Haixia Shang, Doctor
Phone:
13623678770
Email:
shx_mail2004@163.com
Facility:
Name:
Affiliated Cancer Hospital of Xinjiang Medical University
Address:
City:
Ürümqi
Zip:
830054
Country:
China
Contact:
Last name:
Guqun Shen, Master
Phone:
18609007670
Email:
382709897@qq.com
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650118
Country:
China
Contact:
Last name:
Linlin Yang, Doctor
Phone:
13085369125
Email:
yll194900@sina.com
Facility:
Name:
Maternal Health School of Medicine Zhejiang University
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Contact:
Last name:
Xiaodong Cheng, Doctor
Phone:
13958039839
Email:
chengxd@zju.edu.cn
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Contact:
Last name:
Hanmei Lou, Master
Phone:
13456856364
Email:
louhm@zjcc.org.cn
Facility:
Name:
The Affiliated People's Hospital of Ningbo University
Address:
City:
Ningbo
Zip:
315201
Country:
China
Contact:
Last name:
Jun Chen, Master
Phone:
13777975439
Email:
cjcj992@163.com
Facility:
Name:
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100006
Country:
China
Contact:
Last name:
Yue He, Doctor
Phone:
13681565788
Email:
yueyue870610@ccmu.edu.cn
Facility:
Name:
Beijing Chaoyang Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100020
Country:
China
Contact:
Last name:
Hua Li, Doctor
Phone:
18600878877
Email:
hual_gyn@163.com
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400032
Country:
China
Contact:
Last name:
Dong Wang, Bachelor
Phone:
13708301293
Email:
cqwindow120@163.com
Facility:
Name:
The Southwest Hospital of Amu
Address:
City:
Chongqing
Zip:
400038
Country:
China
Contact:
Last name:
Yanzhou Wang, Doctor
Phone:
18680893816
Email:
wangyanzhou1981@126.com
Facility:
Name:
Chongqing University Three Gorges Hospital
Address:
City:
Chongqing
Zip:
400040
Country:
China
Contact:
Last name:
Shichuan Chang, Master
Phone:
17323861001
Email:
cshchuan@sina.com
Facility:
Name:
The Second Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400072
Country:
China
Contact:
Last name:
Xiaojing Dong, Doctor
Phone:
13648437247
Email:
xffdoctor@163.com
Facility:
Name:
The Affiliated Hospital of Southwest Medical University
Address:
City:
Chongqing
Zip:
646000
Country:
China
Contact:
Last name:
Dan Li, Doctor
Phone:
15884169140
Email:
lidan0918@163.com
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Xiaohua Wu, Doctor
Phone:
18121299168
Email:
wu.xh@fudan.edu.cn
Facility:
Name:
Shanghai Tenth People's Hospital
Address:
City:
Shanghai
Zip:
200040
Country:
China
Contact:
Last name:
Xiaojun Chen, Doctor
Phone:
13601680784
Email:
cxjlhjj@163.com
Facility:
Name:
Obstetrics & Gynecology Hospital of Fudan University
Address:
City:
Shanghai
Zip:
200090
Country:
China
Contact:
Last name:
Xuezhen Luo, Doctor
Phone:
13472887368
Email:
xuezhenluo2013@163.com
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Contact:
Last name:
Ke Wang, Master
Phone:
18622221098
Email:
18622221098@163.com
Facility:
Name:
Tianjin Central Hospital of Gynecology Obstetrics
Address:
City:
Tianjin
Zip:
300199
Country:
China
Start date:
July 2024
Completion date:
June 2029
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06475599
