Cancer
Conditions
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.
Interventions
OTHERObservational study
Observational study of this study, no interventions involved
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* In patients with malignant tumor who have been treated with albumin-bound paclitaxel for the treatment.
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed