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

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

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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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