Percutaneous Holmium Injection in Pancreatic Cancer

Korábbi kezelés

• Radiation therapy within the last 4 weeks before the start of study therapy.
• Chemotherapy within the last 2 weeks before the start of study therapy.
• Any unresolved toxicity ≥ grade 3 from the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 5.0) from previous anti-cancer therapy.
• Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.

Más betegség

• Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.

Laborértékek

• Leukocytes < 3.0 10\^9/l and/or platelet count < 75 10\^9/l.
• Kidney failure: Creatine > 165 µmol/l and/or eGFR < 60 ml/min/1,73m\^2

Egyéb

• Calcifications in the pancreas or tumour that are highly expected to obstruct the needle tract
• Patient is deemed ineligible for implantation of 166Ho by an expert panel (surgeon, nuclear medicine physician, interventional radiologist, radiologist, and researcher) due to tumour anatomy, nearby structures, patient status or a combination.
• Pregnancy or breast feeding (women of child-bearing potential).
• Patients who are declared incompetent.

• Female or male aged 18 years and over.
• Pathologically proven pancreatic adenocarcinoma, also known as pancreatic ductal adenocarcinoma.
• Patient is deemed ineligible for surgical resection of the pancreatic cancer:
  • in accordance with consensus at the multidisciplinary meetings/discussions,
  • and/or the patient refuses to undergo surgical resection out of personal choice
• Life expectancy of 16 weeks or longer.
• World Health Organisation (WHO) Performance status 0-1
• One or more measurable pancreatic tumours of at least 20 mm in the longest diameter by spiral CT or MRI according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
• Negative pregnancy test for women of childbearing potential.