EUCTR2020-000560-37-IT进行中（未招募）1 期
Pressurized intraperitoneal aerosol chemotherapy in patients with peritoneal carcinomatosis. PIPAC-IOV study. Single-center, single-arm open-label phase II clinical trial - IOV-CAR-01-2020 PIPAC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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
- •- Male or female = 18 years of age
- •- ECOG performance status 0–2.
- •- Histologically or cytologically documented gastrointestinal or ovarian cancer (based on tissue from the primary tumor and/or its metastases); other cancer can be included based on a careful multidisciplinary assessment of the risk benefit of the procedure in the specific patient
- •- Radiological, histological or cytological evidence of peritoneal metastases
- •- Not eligible for curative surgery and/or HIPEC according to National Guidelines
- •- ife expectancy of at least 24 weeks;
- •- Laboratory Requirements:
- •- Neutrophils = 1.5 x 109/L;
- •- Platelets = 100 x 109/L;
- •- Hemoglobin = 9 g/dL;
- •- Total bilirubin = 1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (SGPT) = 2.5 x UNL;
- •- Alkaline phosphatase = 2.5 x UNL;
- •- Creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula or serum creatinine =1.5 x UNL;
- •- Negative serum or urine pregnancy test at screening for women of childbearing potential. Female subjects, or male subjects with female partners of child-bearing potential must be willing to use highly effective contraception as approved by the investigator (i.e. barrier contraceptive measure or oral contraception, total abstinence) during the study and until 30 days after last study treatment;
- •- Written informed consent to the study participation according to the Local Ethic Committee requirements before any study procedure;
- •- Will and ability to comply with the protocol.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Any surgery apart from staging laparoscopy less than 4 weeks before inclusion;
- •- Extra peritoneal metastasis; patients with limited extra peritoneal metastatic disease can be enrolled based on mdt discussion;
- •- Bowel obstruction or parenteral nutrition or gastric tube;
- •- A history of allergic reaction or contraindication to platinum containing compounds or doxorubicin;
- •- Any significant disease which, in the investigator’s opinion, excludes the patient from the study;
- •- Myocardial insufficiency, defined as NYHA class >3
- •- Renal impairment, defined as glomerular filtration rate (GFR) < 30 ml/min
- •- Impaired liver function defined as bilirubin > 1.5 UNL (except in presence of Gilbert disease)
- •- Pregnancy or breastfeeding;
- •- Untreated central nervous system disease, history or evidence of thrombotic or hemorrhagic disorders not considered currently in complete remission;
- •- Active infection requiring antibiotics;
- •- Medical, geographical, sociological, psychological, or legal conditions that would prevent the patient from completing the study or signing the informed consent;
研究者
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