A Real-world Study of Albumin-bound Paclitaxel in the Treatment of Pancreatic Cancer

December 6, 2018 updated by: Baorui Liu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

A Real-world Study of on Albumin-bound Paclitaxel as First-line Treatment of Patients With Non-operative Locally Advanced or Metastatic Pancreatic Cancer

Pancreatic cancer progresses rapidly and has a higher death rate. Albumin-bound paclitaxel is a new generation of paclitaxel . Albumin-bound paclitaxel is recommended as a class 1A evidence treating patients with pancreatic cancer.The purpose of this study was to further observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel in the treatment of non-operative locally advanced or metastatic pancreatic cancer and to explore the prognostic factors .

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a prospective, single-arm, observational study. After the subjects meet the inclusive and exclusive criteria, then they will receive albumin-bound paclitaxel treatment. The researchers can choose the treatment based on albumin-bound paclitaxel and choose dosage according to the patient's condition.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • The Affiliated Hospital of Nanjing University Medical School

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hospital

Description

Inclusion Criteria:

  1. Age: 18 -80, male or female;
  2. Non-operative patients with locally advanced or metastatic pancreatic cancer diagnosed by pathology or histology (except islet cell carcinoma);
  3. The patient has not received standard systematic treatment in the past, and the metastatic site has not received any local treatment, including radiotherapy, chemotherapy, surgical treatment, etc.;
  4. At least one measurable lesion (CT scan length of tumor lesion is greater than 10 mm, CT scan short diameter of lymph node lesion is greater than 15 mm, scanning layer thickness is not greater than 5 mm);
  5. The subjects volunteered to participate in this study and signed the informed consent form, with good compliance to follow-up.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Patients allergy to albumin-bound paclitaxel or its excipients
  3. Patients with albumin-bound paclitaxel contraindication;
  4. Doctors consider those who are not suitable for this study.

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
Progression free survival
Time Frame: 3 weeks
the date from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first.
3 weeks

Collaborators and Investigators

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: Baorui Liu, Doctor, The Affiliated Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

December 20, 2018

Primary Completion (Anticipated)

December 20, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

December 10, 2018

Last Update Submitted That Met QC Criteria

December 6, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXPLORE-PC101

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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