Phase
Condition
Endometrial Cancer
Treatment
TQB2450
Anlotinib
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Understood and signed an informed consent form. 2. Eastern Cooperative OncologyGroup (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
Histopathologically confirmed recurrent or metastatic advanced endometrialcancer.
Has at least one measurable lesion. 5. Agree to provide tumor tissue samplesfor MSI/MMR status detection. 6. Adequate laboratory indicators. 7. Serum orurine pregnancy tests are negative within 7 days before randomization; Men andwomen should agree to use effective contraception during the study period andafter the end of the study period within 6 months.
Exclusion
Exclusion Criteria:
- 1.Concomitant disease and medical history:
Has diagnosed and/or treated additional malignancy within 3 years prior torandomization;
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 daysbefore the start of the study.
Has a unhealed wound or fracture for a long time;
Has cerebrovascular accident, deep vein thrombosis and pulmonary embolismwithin 6 months before the study;
Has uncontrollable pleural effusion, pericardial effusion, or ascites requiringrecurrent drainage procedures;
Has a history of psychotropic substance abuse and unable to quit or mentaldisorders;
Has any serious and / or uncontrolled disease; 2. Tumor-related symptoms andtreatment:
Has received surgery, chemotherapy, radiotherapy or other anticancer therapywithin 4 weeks before the start of the study;
Has received proprietary Chinese medicine with anti-tumor indications in theNMPA approved drug instructions within 2 weeks before the start of the study;
Has received immunotherapeutic drugs against PD-1, PD-L1, CTLA-4 and otherrelated 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 thefirst dose ;
CT or MRI showed that the tumor had invaded the important blood vessels;
Has symptomatic central nervous system (CNS) disease and/or cancerousmeningitis, pia mater disease; 3. Related to research and treatment:
Has received attenuated live vaccine within 28 days before randomization orplanned 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 2years before the study.
Has Participated in other clinical trials within 4 weeks before firstdose. 5. According to the judgement of the investigators, there are otherfactors that may lead to the termination of the study.
Study Design
Connect with a study center
Anhui Provincial Hospital
Hefei, Anhui 230001
ChinaSite Not Available
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui 230601
ChinaSite Not Available
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing 100016
ChinaSite Not Available
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing 101149
ChinaSite Not Available
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing 100016
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing, Beijing 100730
ChinaSite Not Available
Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital
Beijing, Beijing 101100
ChinaSite Not Available
Chongqing University Cancer Hospital
Chongqing, Chongqing 400030
ChinaSite Not Available
Gansu Province Maternity and Chid-care Hospital
Lanzhou, Gansu 730050
ChinaSite Not Available
Gansu Provincial Hospital
Lanzhou, Gansu 730000
ChinaSite Not Available
Lanzhou University Second Hospital
Lanzhou, Gansu 730030
ChinaSite Not Available
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510289
ChinaSite Not Available
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510080
ChinaSite Not Available
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi 530022
ChinaSite Not Available
Affiliated Hospital of Hebei University
Baoding, Hebei 071002
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 4500003
ChinaSite Not Available
Hunan Cancer Hospital
Changsha, Hunan 410013
ChinaSite Not Available
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia 010000
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210009
ChinaSite Not Available
The First Bethune Hospital of Jilin University
Changchun, Jilin 130021
ChinaSite Not Available
Liaoning Cancer Hospital
Shenyang, Liaoning 110041
ChinaSite Not Available
Binzhou Medical University Hospital
Binzhou, Shandong 256600
ChinaSite Not Available
Linyi Cancer Hospital
Linyi, Shandong 276034
ChinaSite Not Available
Qingdao Central Hospital
Qingdao, Shandong 266042
ChinaSite Not Available
Weifang People's Hospital
Weifang, Shandong 261000
ChinaSite Not Available
Yantai Yuhuangding Hospital
Yantai, Shandong 264000
ChinaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai, Shanghai
ChinaSite Not Available
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai 200090
ChinaSite Not Available
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi 030001
ChinaSite Not Available
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi 710061
ChinaSite Not Available
Xi'an People's Hospital
Xi'an, Shanxi 710004
ChinaSite Not Available
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin 300052
ChinaSite Not Available
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin 300060
ChinaSite Not Available
First Affiliated Hospital, School of Medicine, Shihezi University
Shihezi, Xinjiang Uygur Autonomous Region 832008
ChinaSite Not Available
The First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang Uygur Autonomous Region 830000
ChinaSite Not Available
Xinjiang Medical University Affiliated Tumor Hospital
Urumqi, Xinjiang Uygur Autonomous Region 830000
ChinaSite Not Available
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310000
ChinaSite Not Available
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang 317000
ChinaSite Not Available
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