Here is the design of a clinical trial:

Official Title: 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

Included conditions:
- Pancreatic Cancer
- Metastasis
- Surgery
- Oligometastatic Disease

Study Armgroups:
- {'label': 'NAPOX chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'NAPOX chemotherapy in 14-day cycles with the four IMPs given intravenously in the following order: nal-irinotecan, oxaliplatin, folinic acid and 5-fluouracil.', 'interventionNames': ['Drug: nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)']}

Interventions:
- {'type': 'DRUG', 'name': 'nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)', 'description': 'preoperative chemotherapy', 'armGroupLabels': ['NAPOX chemotherapy'], 'otherNames': ['nal-irinotecan (nal-iri)', 'oxaliplatin (ox)', '5-fluouracil (5-FU)', 'folinic acid (FA)', 'ONIVYDE TM']}

Primary Outcomes:
- {'measure': 'Overall survival after R0/R1 resection (OS-res)', 'description': 'OS for patient after macroscopic tumor resection', 'timeFrame': 'max 24 months follow-up'}

Please estimate the sample size based on the assumption: 
One-sided log-rank test, power of 80%, one-sided significance level of 0.1, accrual period of 14 months, minimum follow-up of 24 months, R0/R1 resection rate of 35%
Statistical hypotheses and sample size determination
        OS after R0/R1 resection (OS-res) will be used as the primary endpoint to assess the efficacy of NAPOX in patients with oligometastatic adenocarcinoma of the pancreas.
        Hence, the hypotheses to be tested are:
H0: median OS-res â¤10âmonthsH1: median OS-res â¥14âmonths
        The hypothesis will be tested with a one-sided log-rank test.
        Since median OS-res of â¥14âmonths is expected, 53 patients and 42 OS-res events are required to test the null hypothesis with a power of 80% at a one-sided significance level of 0.1 (one-sample testing using log-rank test) if an accrual period of 14âmonths (period from FPI to resection approx. 4âmonths) and a minimum follow-up of 24âmonths after resection is assumed. The longer the follow-up duration, the higher is the power to detect a specific alternative effect size. Assuming a R0/R1 resection rate of 35%, 150 patients will be included in this clinical trial.