NCT06700603

Second-line Irinotecan Liposome Combination Regimen for Irinotecan-treated Pancreatic Cancer

Phase II Clinical Study of Irinotecan Liposome Combined with 5-FU/LV for the Patients with Advanced Pancreatic Cancer Who Failed to Receive Irinotecan-containing Regimens

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Rui-hua Xu, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, two-cohort phase II clinical study. It is expected to enroll 48 patients with advanced or metastatic pancreatic cancer who have failed prior treatment with irinotecan-containing regimens, including two cohorts: cohort 1 for patients who have progressed within 6 months of the end of adjuvant therapy for early pancreatic cancer with a prior irinotecan regimen or for patients with imaging-confirmed progression within 3 months of the end of first-line therapy for advanced patients, and cohort 2 for patients who have progressed after more than Cohort 2 was for patients who had progressed more than 6 months after adjuvant treatment with previous irinotecan regimen for early-stage pancreatic cancer or more than 3 months after the end of first-line treatment for advanced-stage patients. The study was conducted at the Cancer Prevention and Control Center of Sun Yat-sen University. The study consists of a screening period (within 28 days), a treatment period (until disease progression or intolerable toxicity occurs in patients), and a follow-up period (12 months, safety follow-up and PFS follow-up). Subjects signed informed consent and underwent baseline examinations during the screening period, and patients who met the inclusion exclusion criteria entered the treatment period, and all subjects perfected the relevant examinations specified in the protocol during the treatment to observe safety, tolerability and efficacy. The same subject received only one dosing schedule during the study period. After the treatment period was completed, a follow-up period was entered.

Detailed description

Evaluation of the efficacy and safety of irinotecan liposomes in combination with 5-FU/levulinic acid sodium in the treatment of patients with irinotecan-containing regimens for treated advanced pancreatic cancer Prospective, single-arm, dual-cohort phase II clinical study. Cohort 1: Patients with imaging-confirmed progression during or within 3 months of completion of irinotecan treatment Cohort 2: Patients with imaging-confirmed disease progression 3 months after completion of irinotecan treatment

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate	Irinotecan liposome (Nal-IRI) in combination with 5-FU/sodium levofolinate，Every 2 weeks until disease progression or patient develops intolerable toxicity

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-11-22
• Last updated: 2024-11-22