ISRCTN15479959已完成1 期
Treatment of skin tumours with intratumoral interleukin 12 gene electrotransfer in the head and neck region
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35535423/ (added 07/11/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically or cytologically confirmed, previously untreated cutaneous basal cell carcinoma located in head and neck region
- •2. Solitary tumours, with the largest diameter up to 3 cm, in the region where curative surgery is feasible
- •3. Age 18 years or older
- •4. Life expectancy >3 months
- •5. Physical performance in accordance with the Karnofsky scale =70 or <2 in accordance with World Health Organization (WHO) scale
- •6. The patient must be capable of understanding the treatment procedure and possible adverse events, which may arise during treatment
- •7. The patient must be capable of signing the informed consent to participate in the clinical study (voluntary and conscientious consent after education)
- •8. Prior to inclusion in the trial, the patient must be presented at a multidisciplinary advisory team meeting
排除标准
- •1. Known malignancy elsewhere in/on the body
- •2. Lesions not suitable for treatment with GET (invasion into the bone, infiltration of large vessels)
- •3. A life-threatening infection and/or severe heart failure and/or liver failure and/or other life-threatening systemic diseases
- •4. Significantly reduced lung function, which requires the determination of diffusing capacity for carbon monoxide (DLCO). Patients should not be treated if DLCO is abnormal
- •5. Treatment with immunosuppressive drugs, steroids and other drugs that would affect poor wound healing
- •6. Age under 18-years
- •7. Major disruptions in the coagulation system (who does not respond to the standard therapy – replacement of vitamin K or freshly frozen plasma)
- •8. A chronic decline in kidney function (creatinine >150 µmol/l)
- •9. Epilepsy
- •10. Pregnancy and breastfeeding
- •11. Patient’s incapable of comprehending the purpose or course of the trial, or not agreeing to be included in the trial
- •12. Patients unwilling or unable to comply with the protocol requirements and scheduled visits
研究者
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