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

NCT ID: NCT06361316

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer Adjuvant Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Irinotecan liposome injection+ Oxaliplatin +Tegafur

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.

Group Type EXPERIMENTAL

Irinotecan liposome injection

Intervention Type DRUG

Postoperative adjuvant therapy

Interventions

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Irinotecan liposome injection

Postoperative adjuvant therapy

Intervention Type DRUG

Other Intervention Names

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oxaliplatin Tegafur

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients who cannot eat orally and have gastric emptying disorder after surgery;
2. 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;
3. Patients who cannot eat orally and have gastric emptying disorder after surgery;
4. Patients who cannot eat orally and have gastric emptying disorder after surgery;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Kuirong Jiang

OTHER

Sponsor Role lead

Responsible Party

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Kuirong Jiang

archiater

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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KuiRong Jiang, archiater

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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FirstNanjingMU

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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KuiRong Jiang, archiater

Role: CONTACT

15312995688

Facility Contacts

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KuiRong Jiang, archiater

Role: primary

15312995688

Other Identifiers

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CSPC-DEY-PC-JS01

Identifier Type: -

Identifier Source: org_study_id

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