A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor
- Registration Number
- NCT04412564
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant tumor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
-1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- Understood and signed an informed consent form. 3. Histologically or cytologically confirmed advanced malignant solid tumors. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception.
-
-
Has multiple factors affecting oral medication. 2. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 3. Other malignancies occurred within 3 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors.
-
Has a history of hypertension, hypertensive encephalopathy or uncontrolled hypertension.
-
Has cardiovascular and cerebrovascular diseases. 6. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before the first dose.
-
Has central nervous system metastasis and / or spinal cord compression, cancerous meningitis, and meningeal disease.
-
Active hepatitis, HIV positive, syphilis positive. 9. Has a history of psychotropic substance abuse. 10. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
-
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQ-B3101 capsules TQ-B3101 TQ-B3101 capsules 300mg bid administered orally in 28-day cycle.
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) up to 48 weeks Percentage of subjects achieving complete response (CR) and partial response (PR).
Adverse events (AE) and serious adverse events (SAE) up to 48 weeks The occurrence of all adverse events (AE) and serious adverse events (SAE).
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) up to 48 weeks Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Progression free survival (PFS) up to 48 weeks PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.
Overall survival (OS) up to 48 weeks 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.
Trial Locations
- Locations (36)
Shanghai Jiaotong University Affiliated Chest Hospital
🇨🇳Shanghai, Shanghai, China
Anhui Chest Hospital
🇨🇳Hefei, Anhui, China
The Second Hospital of Anhui medical University
🇨🇳Hefei, Anhui, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, Beijing, China
Fujian Provincial Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Cancer Center of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Xiangyang First People's Hospital
🇨🇳Xiangyang, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Weihai Central Hospital
🇨🇳Weihai, Shandong, China
Shanxi Bethuen Hospital
🇨🇳Taiyuan, Shanxi, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
🇨🇳Xi'an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Xi'an Chest Hospital
🇨🇳Xi'an, Shanxi, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
First Affiliated Hospital, School of Medicine, Shihezi University
🇨🇳Shihezi, Xinjiang Uygur Autonomous Region, China
The Affiliated Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang Uygur Autonomous Region, China
Sir Run Run Shaw Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
The Fifth Medical Center of PLA Ceneral Hospital
🇨🇳Beijing, Beijing, China
Liuzhou People's Hospital
🇨🇳Liuzhou, Guangxi Zhuang Autonomous Region, China
Nanyang First People's Hospital
🇨🇳Nanyang, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Luoyang Central Hospital Affiliated to Zhenghzou University
🇨🇳Luoyang, Henan, China
AnYang Tumor Hospital
🇨🇳Anyang, Henan, China
The First People's Hospital of Kashgar Prefecture
🇨🇳Kashgar Prefecture, Xinjiang Uygur Autonomous Region, China
First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang Uygur Autonomous Region, China