A Clinical Applicability Study of the Tumour Specific Electroporation Technique for Patients with Locally Advanced or Recurrent Head & Neck Cancer Using IQwave 3.0 CE.

India Sweden Healthcare Innovation Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1.Patients greater than or equal to 18 years of age.
•2.Any gender of the patient
•3.Histologically confirmed, Recurrent or progressive locally advanced Head & Neck cancers.
•4.Primary tumors do not respond to the available standard of care treatments or are exhausted from chemotherapy and radiation, and are not amenable to surgery.
•5.Patients with primary tumors but medically unfit for any standard treatment
•6.Patient in a physical condition suitable for general anesthesia/local anesthesia
•7.A life expectancy of at least six months.
•8.Patients with an ECOG performance of less than 3.
•9.Signed informed consent document.

•1.Patients who have an extensive and rapidly progressive disease with poor performance status (ECOG > 3) and with a life expectancy of fewer than 3 months.
•2.Patients with tumors seated deeper than three cm from the surface of the skin.
•3.Patients who, for medical reasons, cannot be given bleomycin.
•4.Patients with pre-existing pulmonary disease (COPD).
•5.Patients with implanted devices such as pacemakers or insulin pumps.
•6.If the tumors are located or directly attached to larger blood vessels. (Read IFU of IQwave electroporation device for more information).
•7.Patients with brain metastases treated with surgery and or/radiotherapy who have progressive disease in the brain.
•8.Pregnant or lactating women.
•9.A prior cumulative dose of bleomycin exceeding 400 U.
•10.Less than 14 days from previous cancer treatment (either local or systemic).
•11.Chronic renal failure (Sr. Creatinine > 150 Ã?Âµmol/L).
•12.An inadequate liver function is defined as:
•a.AST or ALT greater than 2.5 x ULN in the absence of liver metastases or greater than 5 in the presence of liver metastases.
•b.Bilirubin greater than 2 x ULN (except in the case of Gilberts Syndrome)
•13.Inadequate bone marrow reserve is defined as:
•a.White blood cell counts less than 3 x 10 /l or Neutrophil count less than 1.5 x 10/ l.
•14.Patient unable, unwilling, or not in a mental stage to comply with the study protocol.

发起方

India Sweden Healthcare Innovation Centre