NCT06006728

Brief Summary

The objectives of the study are to evaluate the efficacy (primary endpoint: overall survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 6, 2023

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

25 days

First QC Date

August 17, 2023

Last Update Submit

January 11, 2024

Conditions

Pancreatic Adenocarcinoma Metastatic

Keywords

pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Up to 3 years

Secondary Outcomes (3)

  • Response rate to treatment

    Every 3 months up to 3 years

  • Progression-free survival

    Every 3 months up to 3 years

  • Cost evaluation

    Every 3 months up to 3 years

Study Arms (1)

naliri

Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patient treated with nanoliposomal irinotecan with fluorouracil and folinic acid for metastatic pancreatic adenocarcinoma after progression with gemcitabine-based treatment

You may qualify if:

  • years or older
  • histological or cytological confirmation of pancreatic ductal adenocarcinoma
  • measurable lesion(s)
  • progression after gemcitabine-based treatment administered in a neoadjuvant, adjuvant protocol (only if remote metastases developed within 6 months of the end of adjuvant treatment), locally advanced, or metastatic phase. They may have already received irinotecan and/or fluorouracil.
  • Performance Status (PS) 0 or 1
  • Oral consent
  • Health insurance

You may not qualify if:

  • symptomatic brain metastases (cerebral edema, corticosteroids, progressive disease)
  • Class III or IV congestive heart failure, ventricular arrhythmia, uncontrolled hypertension.
  • Patient under legal protection
  • Hypersensitivity to irinotecan
  • Breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bordeaux

Pessac, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

October 6, 2023

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)