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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

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 .

Condition or disease
Pancreatic Cancer

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospital
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768687


Contacts
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Contact: Baorui Liu, Doctor 13770621908 baoruiliu07@163.com
Contact: Juan Du, Doctor 13951826526 dujunglyy@163.com

Locations
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China, Jiangsu
The Affiliated Hospital of Nanjing University Medical School Not yet recruiting
Nanjing, Jiangsu, China, 210008
Contact: Baorui Liu, Doctor    13770621908    baoruiliu07@163.com   
Contact: Juan Du, Doctor    13951826526    dujunglyy@163.com   
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
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Principal Investigator: Baorui Liu, Doctor The Affiliated Hospital of Nanjing University Medical School

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Responsible Party: Baorui Liu, chief doctor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03768687     History of Changes
Other Study ID Numbers: EXPLORE-PC101
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baorui Liu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
pancreatic cancer
albumin-bound paclitaxel
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action