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CompletedNCT04060290Updated Feb 28, 2024

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

An observational study in Cancer, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Completed at 14 sites in China. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,000
Sex
All
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Study 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.

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Conditions studied

  • Cancer

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 1,000 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 161 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

malignant tumor

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Patient registry
No

Interventions

  • OtherObservational study

    Observational study of this study, no interventions involved

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What researchers measure

Primary outcomes

  1. Percentage and severity of Participants With Adverse Events (AEs)

    percentage and CTC AE(v5.0) of AEs

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

Secondary outcomes

  1. 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.

    Time frame: From signing informed consent，assessed up to end of study (up to approximately 24months)

  2. evaluate patients' quality of life by the European Cancer Research and Treatment Tissue Cancer Quality Core Questionnaire EORTCQLQ-C30

    EORTC QLQC30 scale was used to score the quality of life before treatment, at each chemotherapy cycle, and at the end of treatment.

    Time frame: From signing informed consent，assessed up to end of study (up to approximately 24months)

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Study locations

14 sites
  • Anhui Cancer Hospital
    Hefei, Anhui, China
  • Maanshan People's Hospital
    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 Autonomous Region, China
  • Liaoning Cancer Hospital
    Shenyang, Liaoning, China
  • Zhongshan Hospital
    Shanghai, Shanghai, 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
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04060290
Lead sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Aug 19, 2019
Start date
May 12, 2020
Primary completion
Feb 1, 2024
Completion
Feb 1, 2024
Last update
Feb 28, 2024

Study contacts

Wei Zhao
study director · Shiyao Group Ouyi Pharmaceutical Co., Ltd.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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