Table 1.

Objectives and endpoints of the HOLIPANC trial

1. Objectives

1.1. Primary Objectives

• To assess the efficacy of neoadjuvant multimodal chemotherapy followed by R0/R1 resection in patients with hepatic oligometastatic adenocarcinoma of the pancreas

1.2. Secondary Objectives

• To determine efficacy and safety of the treatment concept

• To determine health-related quality of life (HR-QoL)

1.3. Other Exploratory Objectives

• To analyze HR-QoL-adjusted overall survival

2. Endpoints

2.1. Primary Endpoint

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

2.2. Secondary Endpoints

Efficacy

• R0/R1 resection rate after neoadjuvant chemotherapy

• Overall survival

• Progression-free survival (PFS) after R0/R1 resection according to RECIST v1.1

Safety

• Type, frequency and severity of adverse events with severity according to NCI CTCAE version 5.0 (neoadjuvant chemotherapy)

• Perioperative morbidity and mortality

Health-Related Quality of Life

• HR-QoL according to EORTC QLQ-C30 and EORTC QLQ-PAN26 questionnaires

2.3. Other, Exploratory Endpoints

• HR-QoL-adjusted OS