- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04574284
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer
A Open-label, Multicenter Phase II Study of TQB2450 Injection or Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Xiaohua Wu, Doctor
- Email: wu.xh@fudan.edu.cn
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230001
- Not yet recruiting
- Anhui Provincial Hospital
-
Contact:
- Weidong Zhao, Doctor
- Email: 13955105591@163.com
-
Principal Investigator:
- Weidong Zhao, Doctor
-
Hefei, Anhui, China, 230601
- Not yet recruiting
- The Second Affiliated Hospital of Anhui Medical University
-
Contact:
- Zhendong Chen
- Email: ay2fychenzhendong@163.com
-
Principal Investigator:
- Zhendong Chen
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Not yet recruiting
- Peking Union Medical College Hospital
-
Contact:
- Lingya Pan, Doctor
- Email: lingyapan@hotmail.com
-
Principal Investigator:
- Lingya Pan, Doctor
-
Beijing, Beijing, China, 100016
- Not yet recruiting
- Beijing Chao-Yang Hospital, Capital Medical University
-
Contact:
- Shuzhen Wang, Doctor
- Email: darrywang2003@163.com
-
Principal Investigator:
- Shuzhen Wang, Doctor
-
Beijing, Beijing, China, 100016
- Not yet recruiting
- Beijing Obstetrics and Gynecology Hospital, Capital Medical University
-
Contact:
- Wei Duan, Doctor
- Email: wduan@263.net
-
Principal Investigator:
- Wei Duan, Doctor
-
Beijing, Beijing, China, 101100
- Not yet recruiting
- Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital
-
Contact:
- Qinping Liao, Doctor
- Email: 13701124527@163.com
-
Principal Investigator:
- Qinping Liao, Doctor
-
Beijing, Beijing, China, 101149
- Not yet recruiting
- Beijing Luhe Hospital Capital Medical University
-
Contact:
- Dong Yan, Doctor
- Email: yd15yt88@163.com
-
-
Chongqing
-
Chongqing, Chongqing, China, 400030
- Not yet recruiting
- Chongqing University Cancer Hospital
-
Contact:
- Dong Wang
- Email: cqwindow120@163.com
-
-
Gansu
-
Lanzhou, Gansu, China, 730030
- Not yet recruiting
- Lanzhou University Second Hospital
-
Contact:
- Pengfei Sun, doctor
- Email: sunpengfeiby@163.com
-
Principal Investigator:
- Pengfei Sun, doctor
-
Lanzhou, Gansu, China, 730000
- Not yet recruiting
- Gansu Provincial Hospital
-
Contact:
- Tiansheng Qing, doctor
- Phone Number: 0931-8281367
- Email: 1689939406@qq.com
-
Principal Investigator:
- Tiansheng Qing, doctor
-
Principal Investigator:
- Hongyi Cai, doctor
-
Lanzhou, Gansu, China, 730050
- Not yet recruiting
- Gansu Province Maternity and Chid-care Hospital
-
Contact:
- Qing Liu, doctor
- Phone Number: 0931-2231215
- Email: 2305470816@qq.com
-
Principal Investigator:
- Qing Liu, doctor
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Not yet recruiting
- Sun Yat-sen University Cancer Center
-
Contact:
- Jundong Li, Master
- Email: lijd@sysucc.org.cn
-
Principal Investigator:
- Jundong Li, Master
-
Guangzhou, Guangdong, China, 510289
- Not yet recruiting
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
-
Contact:
- Bingzhong Zhang, Doctor
- Email: 13925063030@163.com
-
Principal Investigator:
- Bingzhong Zhang, Doctor
-
-
Guangxi
-
Nanning, Guangxi, China, 530022
- Not yet recruiting
- Guangxi Medical University Affiliated Tumor Hospital
-
Contact:
- Deisheng Yao, Doctor
- Email: yaodeson@163.com
-
Principal Investigator:
- Deisheng Yao, Doctor
-
-
Hebei
-
Baoding, Hebei, China, 071002
- Not yet recruiting
- Affiliated Hospital of Hebei University
-
Principal Investigator:
- Aimin Zang
-
Contact:
- Aimin Zang
- Email: booszam@sina.com
-
-
Henan
-
Zhengzhou, Henan, China, 4500003
- Not yet recruiting
- Henan Cancer Hospital
-
Principal Investigator:
- li wang
-
Contact:
- Li Wang
- Email: 13837196622@163.com
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Not yet recruiting
- Hunan Cancer Hospital
-
Contact:
- Jing Wang, Doctor
- Email: wangjing0081@hnca.org.cn
-
Principal Investigator:
- Jing Wang, Doctor
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Not yet recruiting
- Nanjing Drum Tower Hospital
-
Contact:
- Huaijun Zhou, Doctor
- Email: zhouhj2007@126.com
-
Principal Investigator:
- Huaijun Zhou, Doctor
-
-
Liaoning
-
Shenyang, Liaoning, China, 110041
- Not yet recruiting
- Liaoning Cancer Hospital
-
Contact:
- Danbo Wang, Doctor
- Email: wangdanbo@cancerhosp-ln-cmu.com
-
Principal Investigator:
- Danbo Wang, Doctor
-
-
Shandong
-
Binzhou, Shandong, China, 256600
- Not yet recruiting
- Binzhou Medical University Hospital
-
Contact:
- Fangling Ning
- Email: ningfangling@126.com
-
Principal Investigator:
- Fangling Ning
-
Linyi, Shandong, China, 276034
- Not yet recruiting
- Linyi Cancer Hospital
-
Principal Investigator:
- Xiumin Li
-
Contact:
- Xiumin Li
- Email: lyzlyylxm@163.com
-
Qingdao, Shandong, China, 266042
- Not yet recruiting
- Qingdao Central Hospital
-
Contact:
- Li Sun, Doctor
- Email: ningfangling@126.com
-
Principal Investigator:
- Li Sun, Doctor
-
Weifang, Shandong, China, 261000
- Not yet recruiting
- Weifang People'S Hospital
-
Principal Investigator:
- Guohua Yu
-
Contact:
- Guohua Yu
- Email: ghyry@126.com
-
Yantai, Shandong, China, 264000
- Not yet recruiting
- Yantai Yuhuangding Hospital
-
Contact:
- Jianqing Hou, Doctor
- Email: hjq63@126.com
-
Principal Investigator:
- Jianqing Hou, Doctor
-
-
Shanghai
-
Shanghai, Shanghai, China, 200090
- Recruiting
- Obstetrics & Gynecology Hospital of Fudan University
-
Contact:
- Xiaojun Chen, Doctor
- Email: cxjlhjj@163.com
-
Principal Investigator:
- Xiaojun Chen, Doctor
-
Shanghai, Shanghai, China
- Not yet recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Xiaohua Wu, Doctor
- Email: wu.xh@fudan.edu.cn
-
Principal Investigator:
- Xiaohua Wu, Doctor
-
-
Shanxi
-
Taiyuan, Shanxi, China, 030001
- Not yet recruiting
- Second Hospital of Shanxi Medical University
-
Contact:
- Min Hao, Doctor
-
Principal Investigator:
- Min Hao, D
-
Xi'an, Shanxi, China, 710061
- Not yet recruiting
- First Affiliated Hospital of Xi'an JiaoTong University
-
Contact:
- Ruifang An, Doctor
- Email: anruifang@163.com
-
Principal Investigator:
- Ruifang An, Doctor
-
Xi'an, Shanxi, China, 710004
- Not yet recruiting
- Xi'an People's Hospital
-
Contact:
- Xinwen Fang, doctor
- Email: xianxinwen@163.com
-
Principal Investigator:
- Xinwen Fang, doctor
-
-
Tianjin
-
Tianjin, Tianjin, China, 300060
- Not yet recruiting
- Tianjin Medical University Cancer Institute & Hospital
-
Contact:
- Ke Wang, Master
- Email: 18622080116@163.com
-
Principal Investigator:
- Ke Wang, Master
-
Tianjin, Tianjin, China, 300052
- Not yet recruiting
- Tianjin Central Hospital of Gynecology obstetrics
-
Contact:
- Pengpeng Qu, Doctor
- Email: qu.pengpeng@hotmail.com
-
Principal Investigator:
- Pengpeng Qu, Doctor
-
-
Xinjiang Uygur Autonomous Region
-
Shihezi, Xinjiang Uygur Autonomous Region, China, 832008
- Recruiting
- First Affiliated Hospital, School of Medicine, Shihezi University
-
Principal Investigator:
- Ping Gong, Doctor
-
Contact:
- Ping Gong, Doctor
- Email: 18990195455@163.com
-
Urumqi, Xinjiang Uygur Autonomous Region, China, 830000
- Not yet recruiting
- The First Affiliated Hospital of Xinjiang Medical University
-
Contact:
- Cailing Ma, Doctor
- Email: mymcl@sina.com
-
Principal Investigator:
- Cailing Ma, Doctor
-
Urumqi, Xinjiang Uygur Autonomous Region, China, 830000
- Not yet recruiting
- Xinjiang Medical University Affiliated Tumor Hospital
-
Contact:
- Jianlin Yuan
- Email: 1499307418@qq.com
-
Principal Investigator:
- Jianlin Yuan
-
Principal Investigator:
- Gulina Kuerban
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Not yet recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Hanmei Lou
- Email: louhm@zjcc.org.cn
-
Principal Investigator:
- Hanmei Lou
-
Taizhou, Zhejiang, China, 317000
- Not yet recruiting
- Taizhou Hospital of Zhejiang Province
-
Contact:
- Haihua Yang, doctor
- Phone Number: 021-33189900
- Email: cxjlhjj@163.com
-
Principal Investigator:
- Haihua Yang, doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Understood and signed an informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
3. Histopathologically confirmed recurrent or metastatic advanced endometrial cancer.
4. Has at least one measurable lesion. 5. Agree to provide tumor tissue samples for MSI/MMR status detection. 6. Adequate laboratory indicators. 7. Serum or urine pregnancy tests are negative within 7 days before randomization; Men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months.
Exclusion Criteria:
1.Concomitant disease and medical history:
- Has diagnosed and/or treated additional malignancy within 3 years prior to randomization;
- Pathological diagnosed as uterine sarcoma;
- Has multiple factors affecting oral medication;
- Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy.
- Has received major surgical treatment, open biopsy and so on within 28 days before the start of the study.
- Has a unhealed wound or fracture for a long time;
- Has cerebrovascular accident, deep vein thrombosis and pulmonary embolism within 6 months before the study;
- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures;
- Has a history of psychotropic substance abuse and unable to quit or mental disorders;
- Has any serious and / or uncontrolled disease; 2. Tumor-related symptoms and treatment:
- Has received surgery, chemotherapy, radiotherapy or other anticancer therapy within 4 weeks before the start of the study;
- Has received proprietary Chinese medicine with anti-tumor indications in the NMPA approved drug instructions within 2 weeks before the start of the study;
- Has received immunotherapeutic drugs against PD-1, PD-L1, CTLA-4 and other related drugs;
- Has used antiangiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, Sunitinib, regorafenib, fruquintinib, etc;
- Has received hormone therapy for endometrial cancer within a week before the first dose ;
- CT or MRI showed that the tumor had invaded the important blood vessels;
- Has symptomatic central nervous system (CNS) disease and/or cancerous meningitis, pia mater disease; 3. Related to research and treatment:
- Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period.
- Has a history of severe allergic diseases.
Has active autoimmune diseases requiring systemic treatment occurred within 2 years before the study.
4. Has Participated in other clinical trials within 4 weeks before first dose. 5. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TQB2450 + Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
|
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
A multi-target receptor tyrosine kinase inhibitor.
|
Experimental: TQB2450
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
|
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
|
Experimental: Anlotinib
Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
|
A multi-target receptor tyrosine kinase inhibitor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR) evaluated by Independent Review Committee(IRC)
Time Frame: up to 12 months
|
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on IRC.
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR) evaluated by investigator
Time Frame: up to 12 months
|
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator.
|
up to 12 months
|
Disease control rate (DCR)
Time Frame: up to 12 months
|
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
|
up to 12 months
|
Duration of response (DOR)
Time Frame: up to 12 months
|
The time when the participants first achieved complete or partial remission to disease progression.
|
up to 12 months
|
Progression free survival(PFS)
Time Frame: up to 12 months
|
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
|
up to 12 months
|
Overall survival(OS)
Time Frame: up to 18 months
|
OS defined as the time from randomization to death from any cause.
Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
|
up to 18 months
|
DOR rate (≥ 6 months)
Time Frame: up to 6 months
|
The percentage of participants achieved complete or partial remission ≥ 6 months.
|
up to 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQB2450-II-08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Endometrial Cancer
-
Novartis PharmaceuticalsCompletedAdvanced Endometrial CancerBelgium, France, Italy, Canada, Spain, Australia, Germany, United States, Japan, Brazil, Singapore, Russian Federation, Poland
-
Novartis PharmaceuticalsCompletedEndometrial Cancer | VEGF | Solid Tumors and Advanced Endometrial Cancer | Second-line TreatmentItaly, United Kingdom, Spain, Brazil, United States, Korea, Republic of, New Zealand
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingAdvanced Endometrial Cancer, Cervical Cancer and Ovarian CancerChina
-
Shanghai Yunying Medical TechnologyShanghai 10th People's HospitalRecruitingCervical Cancer | Endometrial Cancer | Advanced CancerChina
-
Asan Medical CenterBoryung Pharmaceutical Co., LtdUnknownAdvanced or Recurrent Endometrial CancerKorea, Republic of
-
Sun Yat-sen UniversityRecruitingRecurrent/ Advanced Stage Endometrial Cancer PatientsChina
-
Evergreen Therapeutics, Inc.Not yet recruitingAdvanced Endometrial Cancer
-
GenmabBioNTech SENot yet recruitingAdvanced Endometrial CancerKorea, Republic of, Spain, Belgium, United States, Denmark, Italy
-
Evergreen Therapeutics, Inc.Not yet recruitingAdvanced Endometrial Cancer
-
3D Medicines (Sichuan) Co., Ltd.RecruitingAdvanced Endometrial CancerChina
Clinical Trials on TQB2450
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingA Study of TQB2450 Injection in Subjects With PD-L1 Positive Recurrent or Metastatic Cervical CancerRecurrent or Metastatic Cervical CancerChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingAdvanced Oligometastatic Non-small Cell Lung CancerChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Unknown
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Unknown
-
Jiangxi Provincial Cancer HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingDigestive System Diseases | Gastrointestinal Diseases | Neoplasms by Histologic Type | Neoplasms by Site | Gastrointestinal Neoplasms | Digestive System Neoplasms | Carcinoma, Squamous Cell | Esophageal Neoplasms | Esophageal Diseases | Neoplasms, Squamous Cell | Esophageal Squamous Cell CarcinomaChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownAdvanced Solid TumorsChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingStage III Non-small-cell Lung CancerChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Recruiting
-
Fudan UniversityRecruiting
-
Tianjin Medical University Cancer Institute and...Recruiting