Open-Label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy with Liposomal Irinotecan Combined with Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patients with Hepatic Oligometastatic Adenocarcinoma of the Pancreas (HOLIPANC)

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512951-18-00

Acronym

Uni-Koeln-4067

Enrollment

150

Registered

2024-09-18

Start date

2021-08-06

Completion date

Unknown

Last updated

2025-07-22

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

Conditions

Hepatic Oligometastatic Adenocarcinoma of the Pancreas

Brief summary

Overall survival after R0/R1 resection (OS-res) (only patients with R0/R1 resection)

Detailed description

R0/R1 resection rate after neoadjuvant chemotherapy, Overall Survival, Progression-free survival (PFS) after R0/R1 resection according to RECIST v1.1, Type, frequency and severity of adverse events with severity according to NCI CTCAE version 5.0 (neoadjuvant chemotherapy), Perioperative morbidity and mortality, HR-QoL according to EORTC QLQ-C30 and EORTC QLQ-PAN26 questionnaires, HR-QoL-adjusted OS

Interventions

DRUGFLUOROURACIL

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

DRUGOXALIPLATIN

DRUGFOLINIC ACID

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival after R0/R1 resection (OS-res) (only patients with R0/R1 resection)	—

Secondary

Measure	Time frame
R0/R1 resection rate after neoadjuvant chemotherapy, Overall Survival, Progression-free survival (PFS) after R0/R1 resection according to RECIST v1.1, Type, frequency and severity of adverse events with severity according to NCI CTCAE version 5.0 (neoadjuvant chemotherapy), Perioperative morbidity and mortality, HR-QoL according to EORTC QLQ-C30 and EORTC QLQ-PAN26 questionnaires, HR-QoL-adjusted OS	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

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