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NCT04060290 Clinical Trial

Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors

Cancer Clinical Trial

Official title:
Real-world Study for the Safety of Albumin-Bound Paclitaxel in Malignant Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04060290
Other study ID # CSPC-KAL-AE-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 12, 2020
Est. completion date February 1, 2024

Study information
Verified date February 2024
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date February 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - In patients with malignant tumor who have been treated with albumin-bound paclitaxel for the treatment. Exclusion Criteria: - No

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observational study
Observational study of this study, no interventions involved

Locations
Country Name City State
China Cancer Hospital Chinese Academy of Medical Sciences Beijing
China Hainan General Hospital Haikou Hainan
China The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang
China Tumor Hospital of Harbin Medical University Harbin Heilongjiang
China Anhui Cancer Hospital Hefei Anhui
China Inner Mongolia Autonomous Region Cancer Hospital Hohhot Inner Mongolia Autonomous Region
China Maanshan People's Hospital Maanshan Anhui
China Zhongshan Hospital Shanghai Shanghai
China Liaoning Cancer Hospital Shenyang Liaoning
China The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei
China Shanxi Provincial Cancer Hospital Taiyuan Shanxi
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital) Xi'an Shanxi
China Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)
Lead Sponsor Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage and severity of Participants With Adverse Events (AEs) percentage and CTC AE(v5.0) of AEs 28 days after the end of the last chemotherapy cycle
Secondary Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria. From signing informed consent,assessed up to end of study (up to approximately 24months)
Secondary evaluate patients' quality of life by the European Cancer Research and Treatment Tissue Cancer Quality Core Questionnaire EORTCQLQ-C30 EORTC QLQC30 scale was used to score the quality of life before treatment, at each chemotherapy cycle, and at the end of treatment. From signing informed consent,assessed up to end of study (up to approximately 24months)
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