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

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.

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Key information

Conditions

Cancer Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Anhui Cancer Hospital, Hefei, Anhui, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

observational study

Other

Observational study of this study, no interventions involved

Primary outcomes

Percentage and severity of Participants With Adverse Events (AEs)

Time frame: 28 days after the end of the last chemotherapy cycle

percentage and CTC AE(v5.0) of AEs

Secondary outcomes

Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2024
First posted: Aug 19, 2019
Registry last updated: Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed