Clinical trial NCT04060290: Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors
Official title: Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-19
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: malignant tumor

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.


Eligibility criteria: Inclusion Criteria:

* In patients with malignant tumor who have been treated with albumin-bound paclitaxel for the treatment.

Exclusion Criteria:

* No

Primary outcomes:
measure: Percentage and severity of Participants With Adverse Events (AEs)
timeFrame: 28 days after the end of the last chemotherapy cycle
Secondary outcomes:
measure: Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: From signing informed consent，assessed up to end of study (up to approximately 24months)
measure: evaluate patients' quality of life by the European Cancer Research and Treatment Tissue Cancer Quality Core Questionnaire EORTCQLQ-C30
timeFrame: From signing informed consent，assessed up to end of study (up to approximately 24months)
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Cancer Hospital
state: Anhui
city: Maanshan
country: China
facility: Maanshan People's Hospital
state: Anhui
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Tumor Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Hohhot
country: China
facility: Inner Mongolia Autonomous Region Cancer Hospital
state: Inner Mongolia Autonomous Region
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
state: Shanxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
Study officials:
affiliation: Shiyao Group Ouyi Pharmaceutical Co., Ltd.
name: Wei Zhao
role: STUDY_DIRECTOR
References: