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

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ClinicalTrials.gov Identifier: NCT03768687
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Baorui Liu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Tracking Information
First Submitted Date December 6, 2018
First Posted Date December 7, 2018
Last Update Posted Date December 7, 2018
Estimated Study Start Date December 20, 2018
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2018)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Real-world Study of Albumin-bound Paclitaxel in the Treatment of Pancreatic Cancer
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Patients enrolled in the study underwent whole-gene sequencing based on their willingness to take tumor tissue samples and blood samples.All samples need tissue samples and peripheral blood as control. Tissue samples can be wax blocks, fresh surgical tissues,tissues through puncture biopsy, laparoscopic biopsy and other biopsy. Sampling should be conducted within 1 week before enrollment.
Sampling Method Non-Probability Sample
Study Population hospital
Condition Pancreatic Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 6, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2020
Estimated Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Baorui Liu, Doctor 13770621908 baoruiliu07@163.com
Contact: Juan Du, Doctor 13951826526 dujunglyy@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03768687
Other Study ID Numbers EXPLORE-PC101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Baorui Liu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators Not Provided
Investigators
Principal Investigator: Baorui Liu, Doctor The Affiliated Hospital of Nanjing University Medical School
PRS Account The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Verification Date December 2018