Immunostimulating Interstitial Laser Thermotherapy in Solid Cancers
Maneno muhimu
Kikemikali
Tarehe
Imethibitishwa Mwisho: | 12/31/2018 |
Iliyowasilishwa Kwanza: | 02/14/2016 |
Uandikishaji uliokadiriwa Uliwasilishwa: | 02/18/2016 |
Iliyotumwa Kwanza: | 02/23/2016 |
Sasisho la Mwisho Liliwasilishwa: | 01/28/2019 |
Sasisho la Mwisho Lilichapishwa: | 01/29/2019 |
Tarehe halisi ya kuanza kwa masomo: | 01/31/2016 |
Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 03/31/2018 |
Tarehe ya Kukamilisha Utafiti: | 03/31/2018 |
Hali au ugonjwa
Uingiliaji / matibabu
Device: imILT
Awamu
Vikundi vya Arm
Mkono | Uingiliaji / matibabu |
---|---|
Experimental: imILT Immunostimulating Interstitial Laser Thermotherapy (imILT) | Device: imILT Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. |
Vigezo vya Kustahiki
Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
Jinsia Inastahiki Kujifunza | All |
Hupokea Wajitolea wa Afya | Ndio |
Vigezo | Inclusion Criteria: - Are male or female > 18 years of age - Have histologically confirmed, locally uncontrolled, solid cancer, with or without metastases, that cannot be treated surgically due to unresectability or inoperability - Have one or more tumours assessable by MRI/CT or ultrasound and situated in such a way that at least a part of the tumour can be treated with IMILT without damage to surrounding vital structures or the skin - Are candidates for ablative intervention also outside this study - Have given informed verbal and written consent to participation in the trial - Have an ECOG performance status < 2 (Karnofsky > 60%) - Have stable haematologic, renal and hepatic functions Exclusion Criteria: - Are HIV positive - Have an active autoimmune disease - Are on systemic corticosteroid medication (local treatment with aerosol's and ointment is allowed) - Have known bleeding disorders or are treated with anticoagulant medication - Are pregnant or nursing |
Matokeo
Hatua za Matokeo ya Msingi
1. Treatment effect (Measurement of tumor burden by irRC criteria) [18 months]
Hatua za Matokeo ya Sekondari
1. Inflammatory response in tumor measured by quantification of inflammatory cell populations [18 months]
2. Inflammatory response in circulation measured by quantification of inflammatory cell populations [18 months]
3. Safety (adverse events) [18 months]
4. Evaluation of pain (measured by VAS) [18 months]
5. Evaluation of Quality of Life (using a standardized questionnaire) [18 months]
6. Usability of the device as evaluated by treatment logs [18 months]