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临床试验/NL-OMON56837
NL-OMON56837尚未招募不适用

Treatment of cancer with Immune Checkpoint Inhibition therapy boosted by High-Intensity Focused Ultrasound Histotripsy; the iFOCUS study. - iFOCUS

niversitair Medisch Centrum Utrecht0 个研究点目标入组 24 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99（—）

入选标准

  • •1. Histologically confirmed metastatic or unresectable cancer that progressed
  • •under regular treatment options
  • •2. Age >= 18 years.
  • •3. Has signed and dated written informed consent before performing any study
  • •procedure, including screening.
  • •4. Anticipated life expectancy >= 12 weeks by Investigator judgement.
  • •5. At least one tumor lesion (primary tumor or metastasis) which is amenable to
  • •application of high intensity focused ultrasound histotripsy (determined by a
  • •radiologist with HIFU-expertise).
  • •The lesion must have a distance of <=30 mm to the skin.
  • •At least part of the lesion must have a distance of >=10 mm to the skin and
  • •other vulnerable structures (e.g. large blood vessels). This part should be
  • •sufficient to be able to select at least one HT focus in an area of solid
  • •If the target lesion contains cystic or necrotic regions: the solid component
  • •should be >=10 mm in diameter, sufficient to be able to select at least one
  • •HIFU-HT focus in an area of solid tumor.
  • •6. Sonication will be performed on tumors that have not previously directly
  • •been treated with radiation therapy or surgery unless they showed significant
  • •mass regrowth.
  • •7. Measurable disease (at least one lesion besides the HIFU-HT treated lesion)
  • •on CT according to RECIST V 1.1 criteria or on PET-CT according to PERCIST
  • •criteria as assessed by investigator and local radiology review.
  • •8. Performance status of 0 or 1 on the WHO Performance Scale.
  • •9. Screening laboratory values must meet the following criteria:
  • •WBC >= 2.0x109/L,
  • •Neutrophils >=1.5x109/L
  • •Platelets >=100 x109/L
  • •Hemoglobin >=5.5 mmol/L
  • •Serum creatinine <=1.5 x upper limit of normal (ULN) or calculated creatinine
  • •clearance >=60 mL/minute (<=Grade 1)
  • •Aspartate aminotransferase (AST) <=2.5 x ULN; alanine aminotransferase (ALT)
  • •<=2.5 x ULN; AST/ALT <5 x ULN if liver involvement
  • •Serum bilirubin <=1.5 x ULN or direct bilirubin <=ULN for subjects with total
  • •bilirubin levels >1.5xULN, except in subjects with Gilbert*s Syndrome
  • •10. Patients must agree to use an adequate method of contraception for the
  • •course of the study through 120 days after the last dose of study medication.
  • •11. Patients must be willing to undergo tumor biopsy.

排除标准

  • •1. Presence of known central nervous system, meningeal, or epidural metastatic
  • •disease. However, subjects with known brain metastases are allowed if the brain
  • •metastases are stable for >=4 weeks before the first dose of study treatment.
  • •Stable is defined as neurological symptoms not present or resolved to baseline,
  • •no radiologic evidence of progression, and steroid requirement of prednisone
  • •<=10 mg/day or equivalent.
  • •2. Patients currently participating and receiving study therapy or patients who
  • •participated in a study of an investigational agent and received study therapy
  • •or used an investigational device within 4 weeks prior to the first dose of the
  • •study treatment.
  • •3. Prior chemotherapy, targeted small molecule therapy or monoclonal antibodies
  • •within 4 weeks prior to the first dose of the study treatment.
  • •4. Prior radiotherapy within 8 weeks prior to the first dose of the study
  • •treatment. The patient will be excluded from the study if the only targetable
  • •lesion has directly been treated with radiation therapy in the past with an
  • •exception for lesions that showed massive regrowth.
  • •5. Prior surgery or ablative therapy within 4 weeks prior to the first dose of
  • •the study treatment. The patient will be excluded from the study if the only
  • •targetable lesion has directly been treated with ablative therapy in the past.
  • •6. Ongoing adverse events > Grade 1 due to a previously administered therapy.
  • •Subjects with <= Grade 2 neuropathy, vitiligo, thyroid disorders,
  • •hypocortisolism or alopecia of any grade are an exception to this criterion and
  • •may qualify for the study.
  • •7. History of other malignancies, except adequately treated and a
  • •cancer-related life-expectancy of more than 5 years.
  • •8. Concurrent medical condition requiring the use of immunosuppressive
  • •medications, or immunosuppressive doses of systemic or absorbable topical
  • •corticosteroids; exceeding prednisolone 10 mg or equivalent.
  • •9. Active autoimmune disease that has required systemic treatment in the past 2
  • •years (i.e. with use of disease modifying agents, high-dose corticosteroids or
  • •immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or
  • •physiologic corticosteroid replacement therapy for adrenal or pituitary
  • •insufficiency, etc.) is not considered a form of systemic treatment.
  • •10. Active infection requiring systemic therapy.
  • •11. History of (non-infectious) pneumonitis that required steroids or current
  • •pneumonitis.
  • •12. Known history of active Tuberculosis.
  • •13. Receipt of a live vaccine within 4 weeks prior to the first dose of the
  • •study treatment.
  • •14. Hypersensitivity to any of the study drugs or their excipients.
  • •15. Contra-indications to MR imaging (e.g. certain pacemakers).
  • •Contra-indications to gadolinium-based contrast agents are not an exclusion
  • •criterion, as a different brand of gadolinium can be used or if necessary the
  • •MRI can be performed without contrast.
  • •16. Pregnancy or lactation.
  • •17. Any other medical or social condition that, in the opinion of the Principal
  • •Investigator, might put the subject at risk of harm during the study or might
  • •adversely affect the interpretation of the study data.

研究者

发起方
niversitair Medisch Centrum Utrecht

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