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

NCT04060290 | Completed

• 1 other identifier: CSPC-KAL-AE-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 14

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• 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)

Interventions

Observational study OTHER

Observational study of this study, no interventions involved

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

malignant tumor

You may qualify if:

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

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (14)

Anhui Cancer Hospital

Hefei, Anhui, China

Location

Maanshan People's Hospital

Maanshan, Anhui, China

Location

Hainan General Hospital

Haikou, Hainan, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Tumor Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Inner Mongolia Autonomous Region Cancer Hospital

Hohhot, Inner Mongolia, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)

Xi’an, Shanxi, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 39589666 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Wei Zhao

  Shiyao Group Ouyi Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 19, 2019
• Study Start: May 12, 2020
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CN (14)