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

K

Kuirong Jiang

Status

Enrolling

Conditions

Adjuvant Therapy
Pancreatic Cancer

Treatments

Drug: Irinotecan liposome injection

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06361316
CSPC-DEY-PC-JS01

Details and patient eligibility

About

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.

Enrollment

53 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

53 participants in 1 patient group

Irinotecan liposome injection+ Oxaliplatin +Tegafur
Experimental group
Description:
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.
Treatment:
Drug: Irinotecan liposome injection

Trial contacts and locations

1

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Central trial contact

KuiRong Jiang, archiater

Data sourced from clinicaltrials.gov

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