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

• Conditions: Pancreatic Cancer

• Registration Number: NCT03768687
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief 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 .

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 Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Last Update Submitted: 2018-12-06
• Study First Posted: 2018-12-07
• Last Update Posted: 2018-12-10
• Study Start: 2018-12-20
• Primary Completion: 2019-12-20
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China