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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03768687
• Other study ID #: EXPLORE-PC101
• Status: Not yet recruiting
• Start date: December 20, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2018
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Baorui Liu, Doctor
• Phone: 13770621908
• Email: baoruiliu07[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 1, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
China	The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	the date from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first.	3 weeks