CTRI/2022/09/045315Not yet recruitingPhase 2
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 Centre1 site in 1 country30 target enrollmentStarted: September 13, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To evaluate tumor size reduction after treatment with Tumour Specific Electroporation using the Electroporation device system, IQwave 3.0 CE.
Study Overview
Brief Summary
This is an academic-driven project. India-Sweden Healthcare Innovation Centre has onboarded its technology partner Scandinavian ChemoTech AB. This is a post-market clinical follow-up study (PMCF), a single-arm, non-randomized study with 30 patients presented with locally advanced head and neck cancer, aiming to reduce tumor size and improve the patient’s quality of life (QOL). Patients who meet the eligibility criteria shall be enrolled in this study. Each patient will be subjected to receive a minimum of two cycles of TSE treatments.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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
- •9.Signed informed consent document.
Exclusion Criteria
- •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 µmol/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.
Outcomes
Primary Outcomes
To evaluate tumor size reduction after treatment with Tumour Specific Electroporation using the Electroporation device system, IQwave 3.0 CE.
Time Frame: 1. 3 months | 2. 6 months
Secondary Outcomes
- To measure the improvement of the patient’s quality of life (QOL) and to assess the patient’s immunological response after treatment with Tumour Specific Electroporation using the Electroporation device system, IQwave 3.0 CE.(6 months after first treatment)
Investigators
Study Sites (1)
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