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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other | Observational study of this study, no interventions involved |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| evaluate patients' quality of life by the European Cancer Research and Treatment Tissue Cancer Quality Core Questionnaire EORTCQLQ-C30 |
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Inclusion Criteria:
Exclusion Criteria:
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malignant tumor
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zhao | Shiyao Group Ouyi Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Cancer Hospital | Hefei | Anhui | China | |||
| Maanshan People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39589666 | Derived | He F, Sun Y, Zhang W, Wu Q, Xu D, Bai Z, Hao Z, Feng W, Zhang K, Liu J, Dong M, Liu G, Li G. Safety and efficacy of generic nab-paclitaxel-based therapy in Chinese patients with malignant tumors in a real-world setting: a multicenter prospective observational study. Discov Oncol. 2024 Nov 26;15(1):712. doi: 10.1007/s12672-024-01609-6. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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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) |
| Maanshan |
| Anhui |
| China |
| Hainan General Hospital | Haikou | Hainan | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| Tumor Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| Inner Mongolia Autonomous Region Cancer Hospital | Hohhot | Inner Mongolia | China |
| Liaoning Cancer Hospital | Shenyang | Liaoning | China |
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 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 |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | China |