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

February 26, 2024 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
          • Li guohui
    • Anhui
      • Hefei, Anhui, China
        • Anhui Cancer Hospital
        • Contact:
          • Sun yancai
      • Maanshan, Anhui, China
        • Maanshan People's Hospital
    • Hainan
      • Haikou, Hainan, China
        • Hainan General Hospital
    • Hebei
      • Shijiazhuang, Hebei, China
        • The Fourth Hospital of Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Tumor Hospital of Harbin Medical University
        • Contact:
          • Mei Dong
    • Henan
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
        • Contact:
          • Zhang wenzhou
    • Inner Mongolia Autonomous Region
      • Hohhot, Inner Mongolia Autonomous Region, China
        • Inner Mongolia Autonomous Region Cancer Hospital
        • Contact:
          • Bai zaixian
    • Liaoning
      • Shenyang, Liaoning, China
        • Liaoning Cancer Hospital
        • Contact:
          • Liu Guangxuan
    • Shanghai
      • Shanghai, Shanghai, China
        • Zhongshan hospital
    • Shanxi
      • Taiyuan, Shanxi, China
        • Shanxi Provincial Cancer Hospital
      • Xi'an, 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)
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

malignant tumor

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days after the end of the last chemotherapy cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
From signing informed consent，assessed up to end of study (up to approximately 24months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

  • Study Director: Wei Zhao, Shiyao Group Ouyi Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2020

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 19, 2019

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-KAL-AE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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