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

ConditionsPancreatic CancerAdjuvant Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKuirong Jiang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Irinotecan liposome injection

    Drug

    Postoperative adjuvant therapy

Treatment groups

53 Participants
are divided into 1 treatment group
Group A: Irinotecan liposome injection+ Oxaliplatin +TegafurExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
baseline up to approximately 21.6 months.

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

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

Time frame
baseline up to approximately 7 months.
2

Overall Survival, OS

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

Time frame
baseline up to approximately55 months.
3

Quality of life, QOL

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.

Time frame
baseline up to approximately 55 months.
4

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

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kuirong Jiang

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution

CSPC Ouyi Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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