Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors
- Conditions
- Cancer
- Registration Number
- NCT04060290
- Lead Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Brief Summary
This is a multi-center, Prospective, observational study，to evaluate the safety and influencing factors of albumin-bound paclitaxel in the real-world chinese population，and evaluate of the efficacy of albumin-bound paclitaxel in patients with malignant tumors and its impact on quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- In patients with malignant tumor who have been treated with albumin-bound paclitaxel for the treatment.
- No
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage and severity of Participants With Adverse Events (AEs) 28 days after the end of the last chemotherapy cycle percentage and CTC AE(v5.0) of AEs
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) From signing informed consent，assessed up to end of study (up to approximately 24months) ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.
evaluate patients' quality of life by the European Cancer Research and Treatment Tissue Cancer Quality Core Questionnaire EORTCQLQ-C30 From signing informed consent，assessed up to end of study (up to approximately 24months) EORTC QLQC30 scale was used to score the quality of life before treatment, at each chemotherapy cycle, and at the end of treatment.
Trial Locations
- Locations (14)
Anhui Cancer Hospital
🇨🇳Hefei, Anhui, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
Maanshan People's Hospital
🇨🇳Maanshan, Anhui, China
Tumor Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
🇨🇳Xi'an, Shanxi, China
Inner Mongolia Autonomous Region Cancer Hospital
🇨🇳Hohhot, Inner Mongolia Autonomous Region, China
Liaoning Cancer Hospital
🇨🇳Shenyang, Liaoning, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, China