A Real-world Study of Albumin-bound Paclitaxel in the Treatment of Pancreatic Cancer
A Real-world Study of on Albumin-bound Paclitaxel as First-line Treatment of Patients With Non-operative Locally Advanced or Metastatic Pancreatic Cancer
1 other identifier
observational
300
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2018
CompletedFirst Posted
Study publicly available on registry
December 7, 2018
CompletedStudy Start
First participant enrolled
December 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedDecember 10, 2018
December 1, 2018
1 year
December 6, 2018
December 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
the date from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first.
3 weeks
Eligibility Criteria
hospital
You may qualify if:
- Age: 18 -80, male or female;
- Non-operative patients with locally advanced or metastatic pancreatic cancer diagnosed by pathology or histology (except islet cell carcinoma);
- 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.;
- 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);
- The subjects volunteered to participate in this study and signed the informed consent form, with good compliance to follow-up.
You may not qualify if:
- Pregnant or lactating women;
- Patients allergy to albumin-bound paclitaxel or its excipients
- Patients with albumin-bound paclitaxel contraindication;
- Doctors consider those who are not suitable for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Related Publications (1)
Dai W, Qiu X, Lu C, Zou Z, Sha H, Kong W, Liu B, Du J. AGIG Chemo-Immunotherapy in Patients With Advanced Pancreatic Cancer: A Single-Arm, Single-Center, Phase 2 Study. Front Oncol. 2021 Oct 13;11:693386. doi: 10.3389/fonc.2021.693386. eCollection 2021.
PMID: 34722242DERIVED
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baorui Liu, Doctor
The Affiliated Hospital of Nanjing University Medical School
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief doctor
Study Record Dates
First Submitted
December 6, 2018
First Posted
December 7, 2018
Study Start
December 20, 2018
Primary Completion
December 20, 2019
Study Completion
June 1, 2020
Last Updated
December 10, 2018
Record last verified: 2018-12