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CancerNCT04060290

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

An observational study of Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cancer
What is being tested?
Observational study
How many people
1,000 participants
Where
14 sitesChina
Study dates
12 May 2020to 1 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: malignant tumor

Who may be able to join

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

Who cannot join

  • No

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

  • Hainan General Hospital

    Haikou, Hainan

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Tumor Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Anhui Cancer Hospital

    Hefei, Anhui

  • Inner Mongolia Autonomous Region Cancer Hospital

    Hohhot, Inner Mongolia

  • Maanshan People's Hospital

    Maanshan, Anhui

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality

  • Liaoning Cancer Hospital

    Shenyang, Liaoning

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

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

    Xi’an, Shanxi

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

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
Being tested
Observational study
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational studyOther

    Observational study of this study, no interventions involved

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    percentage and CTC AE(v5.0) of AEs

    Measured: 28 days after the end of the last chemotherapy cycle

Secondary outcomes (2)

  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2019
  2. Study start12 May 2020
  3. Primary completion1 Feb 2024
  4. Study completion1 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04060290
Sponsor's protocol ID
CSPC-KAL-AE-01
Status last verified
Feb 2024
First submitted
14 Aug 2019
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39589666

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage and severity of Participants With Adverse Events (AEs) (time frame: 28 days after the end of the last chemotherapy cycle). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04060290, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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