EUCTR2011-003751-19-NL进行中（未招募）不适用
An open-label, single arm, multi-centre, Phase II study to evaluate the safety and efficacy of PC-A11 with superficial and interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be eligible to participate in this study, patients must meet the following eligibility criteria:
- •1.Study eligibility reviewed and approved by interdisciplinary hospital team.
- •2.Age = 18 years.
- •3.Histologically or cytologically confirmed diagnosis of recurrent or metastatic SCCHN considered unsuitable for surgery and radiotherapy (patients with distant or regional metastatic disease may be eligible if local palliation is needed).
- •4.Performance status (ECOG = 1).
- •5.At least one measurable target lesion at baseline.
- •6.Local disease including margins (0.5 cm) treatable with superficial and/or interstitial laser light application (for superficial lesions: entire tumour assessable for laser light application / interstitial treatment: insertion of implants feasible)
- •7.Estimated life expectancy of at least 12 weeks.
- •8.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 52
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Prior Treatment:
- •1.Local treatment (e.g. surgery or radiation) of their SCCHN by surgery within the previous 4 weeks or by radiation within the previous 3 months.
- •2.Previous treatment with systemic chemotherapy for their SCCHN within the last 4 weeks.
- •3.Previous treatment with Photodynamic Therapy within the last 6 months.
- •4.Prior treatment with bleomycin.
- •5.Prior treatment with PC-A11.
- •6.Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) which did not resolve to = grade 2 (as defined by CTCAE version 4.0).
- •Current Treatment:
- •7.Current or recent (within 30 days of first study treatment) treatment with another investigational drug or participation in another investigational study.
- •8.Other concurrent anticancer therapies.
- •9.Treatment with a medicinal product with known or potential drug-drug interaction with bleomycin or Amphinex.
- •Haematology, coagulation and biochemistry:
- •10.Inadequate bone marrow function:
- •Absolute Neutrophil Count (ANC): < 1.5 x 109/L, or platelet count <100 x 109/L or haemoglobin < 6 mmol/L.
- •11.Inadequate liver function, defined as:
- •Serum (total) bilirubin > 2 x the Upper Limit of Normal (ULN) for the institution.
- •Aspartate Amino Transferase (ASAT) or Alanine Amino Transferase (ALAT) > 2.5 x ULN.
- •Alkaline phosphatase levels > 2.5 x ULN.
- •12.Glomerular filtration rate (GFR) < 60ml/min.
- •13.Clinical significant electrolyte abnormalities (Potassium, Magnesium, Phosphate that is greater than CTCAE grade 3 for both low and high values)
- •14.Tumours known or suspected to be eroding into a major blood vessel, e.g. carotid artery (interna and /or communis) in or adjacent to the illumination site (minimum distance between tumour tissue and critical structure should be 0.5 cm).
- •15.Nasopharyngeal carcinoma.
- •16.Conditions contraindicated for bleomycin treatment (current lung infection, severely impaired pulmonary function) excluded by lung function test (either formal lung function test for patients able to undertake such assessment, or a suitable opinion by an appropriately trained Respiratory / Anaesthetic Clinical Specialist).
- •17.Conditions that worsen when exposed to light (including porphyria).
- •18.Inability to undergo CT or MRI.
- •19.Pregnancy or lactation (female patients with childbearing potential). Serum pregnancy test to be performed within 7 days prior to study PC-A11 treatment start, or within 14 days followed by a confirmatory urine pregnancy test within 7 days prior to study treatment start.
- •20.For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients who are not surgically sterile or with female partners of childbearing potential: absence of highly effective method of contraception resulting in a low failure rate (i.e. less than 1% per year). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy. Note: Abstinence is only acceptable as true abstinence: when this is in line with the preferred and usual lifestyle of the subject, periodic abstinence (eg calender, ovulation, symptothermal,
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