Here is the design of a clinical trial:

Official Title: PanDox: Feasibility of Enhanced Chemotherapy Delivery to Non-resectable Primary Pancreatic Tumours Using Thermosensitive Liposomal Doxorubicin (ThermoDox®) and Focused Ultrasound

Included conditions:
- Pancreatic Ductal Adenocarcinoma
- Pancreatic Cancer Stage IV
- Pancreatic Cancer Non-resectable
- Pancreatic Cancer Metastatic

Study Armgroups:
- {'label': 'Arm A (Doxorubicin)', 'type': 'ACTIVE_COMPARATOR', 'description': 'a single intravenous dose of Doxorubicin, 50 mg/ m2 in 250 mL of normal saline or 5% dextrose over a 30-min infusion is delivered as per local practice.', 'interventionNames': ['Drug: Doxorubicin']}
- {'label': 'Arm B (ThermoDox + Focused Ultrasound)', 'type': 'EXPERIMENTAL', 'description': 'under general anaesthetic, patients receive FUS, which is moved through the target tumour volume to raise the bulk tumour temperature above the thermal release threshold. At presumed target temperature, a single intravenous dose of ThermoDox®, 50 mg/ m2 in 250 mL of normal saline or 5% dextrose over a 30-min infusion is delivered concurrently to FUS, in line with the pharmacy manual provided by the manufacturer. FUS will continue following infusion, for no longer than two hours from infusion commencing.', 'interventionNames': ['Device: Focused Ultrasound', 'Drug: ThermoDox']}

Interventions:
- {'type': 'DEVICE', 'name': 'Focused Ultrasound', 'description': 'Focused ultrasound targetting the tumour at subablative powers, to facilitate drug release', 'armGroupLabels': ['Arm B (ThermoDox + Focused Ultrasound)']}
- {'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'Doxorubicin infusion', 'armGroupLabels': ['Arm A (Doxorubicin)']}
- {'type': 'DRUG', 'name': 'ThermoDox', 'description': 'ThermoDox infusion', 'armGroupLabels': ['Arm B (ThermoDox + Focused Ultrasound)']}

Primary Outcomes:
- {'measure': 'To quantify the enhancement in intratumoural doxorubicin concentration when delivered with ThermoDox® and mild hyperthermia generated non-invasively by focused ultrasound (FUS) compared to free drug alone', 'description': 'A statistically significant enhancement in concentration of total intra-tumoural doxorubicin from tumour biopsies at the targeted tumour site receiving drug with FUS compared to drug alone. Quantification of inter-tumoural drug release will be achieved using a GLP HPLC (High Pressure Liquid Chromatography) assay', 'timeFrame': 'within 30 hours of intervention'}

Please estimate the sample size based on the assumption: 
Statistically meaningful enhanced drug delivery will be demonstrated using an unpaired t-test.
Sample size
        The PanDox study is intended to recruit 18 evaluable participants. This sample size reflects that this is a Phase I study and is in line with the available funding resources and likely recruitment rates. Using estimates of mean tissue doxorubicin and standard deviation from the TARDOX trial [10], the participant number is predicted to be large enough to demonstrate statistically meaningful enhanced drug delivery using an unpaired t-test. Additionally, the sample size is small enough to ensure that participants are not unnecessarily recruited and exposed to potential side effects.