Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06361316

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pancreatic Cancer Adjuvant Therapy Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FirstNanjingMU

Nanjing, Jiangsu, 025, China

Location status: Recruiting

Location contact

KuiRong Jiang, archiater

CONTACT

[email protected]

15312995688

Min Tu, associate doctor

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

irinotecan liposome injection

Drug

Postoperative adjuvant therapy

Other names: oxaliplatin, Tegafur

Primary outcomes

  1. Disease Free Survival, DFS

    Time frame: baseline up to approximately 21.6 months.

    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.

Secondary outcomes

  1. 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.

    Hematologic and non-hematologic adverse events during adjuvant therapy (according to NCI-CTCAE5.0);

  2. Overall Survival, OS

    Time frame: baseline up to approximately55 months.

    the time from the start of randomization (or the start of treatment in a one-arm trial) to death from any cause.

  3. Quality of life, QOL

    Time frame: baseline up to approximately 55 months.

    It reflects the ability of human activities to improve the survival level and survival chances, evaluated according to EORTC Quality of life measurement scale QLQ-C30 V3.0 assessment.

  4. 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.

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

  5. 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.

    The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy and the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance

Study contacts

Contact information is provided by the study sponsor or research team.

KuiRong Jiang, archiater

CONTACT

[email protected]

15312995688

Sponsors and collaborators

Lead sponsor

Kuirong Jiang

Other

Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.