NCT06361316

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable pancreatic-cancer

Timeline
28mo left

Started Apr 2024

Typical duration for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress48%
Apr 2024Jul 2028

First Submitted

Initial submission to the registry

March 25, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

April 8, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Expected
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

March 25, 2024

Last Update Submit

April 8, 2024

Conditions

Pancreatic CancerAdjuvant Therapy

Outcome Measures

Primary Outcomes (1)

  • Disease Free Survival, DFS

    the time from the start of randomization (or the start of treatment in a one-arm trial) to the recurrence of disease or death from any cause, whichever occurs first.

    baseline up to approximately 21.6 months.

Secondary Outcomes (5)

  • Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE

    baseline up to approximately 7 months.

  • Overall Survival, OS

    baseline up to approximately55 months.

  • Quality of life, QOL

    baseline up to approximately 55 months.

  • The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy

    baseline up to approximately 7 months.

  • he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance

    baseline up to approximately 7 months.

Study Arms (1)

Irinotecan liposome injection+ Oxaliplatin +Tegafur

EXPERIMENTAL

Oxaliplatin: 60mg/m2, d1, ivgtt, 2h; Repeat every 15 days; Irinotecan liposomes: 50mg/m2, d1, ivgtt, 90min; Repeat every 15 days; Tegafur: 40-60mg, BID, po, d1-d10, repeat every 15 days; 30 days as one cycle, 6 treatment cycles.

Drug: Irinotecan liposome injection

Interventions

Irinotecan liposome injectionDRUG

Postoperative adjuvant therapy

Also known as: oxaliplatin, Tegafur
Irinotecan liposome injection+ Oxaliplatin +Tegafur

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG performance status 0 or 1.
  • Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
  • ECOG performance status 0 or 1.
  • Life expectancy of greater than or equal to 6 months.
  • Able and willing to provide a written informed consent.

You may not qualify if:

  • Patients who cannot eat orally and have gastric emptying disorder after surgery;
  • Patients with moderate diarrhea: diarrhea ≥4 times per day; the moderate and severe effluents from stoma increased; Or diarrhea that limits activities of daily living;
  • Patients who cannot eat orally and have gastric emptying disorder after surgery;
  • Patients who cannot eat orally and have gastric emptying disorder after surgery;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FirstNanjingMU

Nanjing, Jiangsu, 025, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

irinotecan sucrosofateOxaliplatinTegafur

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsFluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • KuiRong Jiang, archiater

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KuiRong Jiang, archiater

CONTACT

15312995688Jiangkuirong@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
archiater

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 11, 2024

Study Start

April 8, 2024

Primary Completion

March 25, 2025

Study Completion (Estimated)

July 31, 2028

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations

CN(1)