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Recruiting NCT06361316

Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer

No phase Interventional Pancreatic Cancer Adjuvant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Irinotecan liposome injection.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Adjuvant Therapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Irinotecan Liposome Injection Combined With Oxaliplatin and Tegafur (NASOX) in Adjuvant Chemotherapy for Pancreatic Cancer

Overview

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.

Interventions

  • Drug Irinotecan liposome injection
    Postoperative adjuvant therapy

Primary outcome measures

  • Disease Free Survival, DFS [Time frame: baseline up to approximately 21.6 months.]
Secondary outcome measures (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 [Time frame: baseline up to approximately 7 months.]
  • Overall Survival, OS [Time frame: baseline up to approximately55 months.]
  • Quality of life, QOL [Time frame: baseline up to approximately 55 months.]
  • The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy [Time frame: 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 [Time frame: baseline up to approximately 7 months.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • FirstNanjingMU — Nanjing

Identifiers

NCT: NCT06361316 · CSPC-DEY-PC-JS01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗