A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer
- Registration Number
- NCT04574284
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
This is a study to evaluate the efficacy and safety of TQB2450 injection or combined with anlotinib hydrochloride capsule in the treatment of recurrent or metastatic advanced endometrial cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 196
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Understood and signed an informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
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Histopathologically confirmed recurrent or metastatic advanced endometrial cancer.
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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.
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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:
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Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period.
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Has a history of severe allergic diseases.
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Has active autoimmune diseases requiring systemic treatment occurred within 2 years before the study.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQB2450 + Anlotinib TQB2450 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 TQB2450 TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle. TQB2450 + Anlotinib 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). Anlotinib 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).
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) evaluated by Independent Review Committee(IRC) 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.
- Secondary Outcome Measures
Name Time Method Progression free survival(PFS) up to 12 months PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Overall survival(OS) 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.
DOR rate (≥ 6 months) up to 6 months The percentage of participants achieved complete or partial remission ≥ 6 months.
Overall response rate (ORR) evaluated by investigator 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.
Disease control rate (DCR) up to 12 months Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of response (DOR) up to 12 months The time when the participants first achieved complete or partial remission to disease progression.
Trial Locations
- Locations (36)
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Chao-Yang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Gansu Provincial Hospital
🇨🇳Lanzhou, Gansu, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
🇨🇳Nanning, Guangxi, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Liaoning Cancer Hospital
🇨🇳Shenyang, Liaoning, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Binzhou Medical University Hospital
🇨🇳Binzhou, Shandong, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
Qingdao Central Hospital
🇨🇳Qingdao, Shandong, China
Weifang People's Hospital
🇨🇳Weifang, Shandong, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Xi'an People's Hospital
🇨🇳Xi'an, Shanxi, China
First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Obstetrics & Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Tianjin Central Hospital of Gynecology Obstetrics
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
First Affiliated Hospital, School of Medicine, Shihezi University
🇨🇳Shihezi, Xinjiang Uygur Autonomous Region, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang Uygur Autonomous Region, China
Xinjiang Medical University Affiliated Tumor Hospital
🇨🇳Urumqi, Xinjiang Uygur Autonomous Region, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
Gansu Province Maternity and Chid-care Hospital
🇨🇳Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, Beijing, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China