A randomized phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509463-24-01

Enrollment

146

Registered

2024-12-12

Start date

2019-11-04

Completion date

Unknown

Last updated

2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic pancreatic cancer

Brief summary

Progression free survival

Detailed description

Overall survival, Response rate according to RECIST 1.1, Adverse events according to NCI CTC version 4.0, Quality of life (QLQ-C30)

Interventions

DRUGOnivyde pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion

DRUGFluorouracil 50mg/ml Injection.

DRUGTeysuno 15 mg/4.35 mg/11.8 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Overall survival, Response rate according to RECIST 1.1, Adverse events according to NCI CTC version 4.0, Quality of life (QLQ-C30)	—

Countries

Austria, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026