EUCTR2018-003112-53-DK进行中（未招募）1 期
Predictive value of in-vitro testing anti-cancer therapy sensitivity on tumoroids from patients with metastatic pancreatic cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
入选标准
- •Non-resectable pancreatic cancer
- •oBiopsy proven adenocarcinoma compatible with pancreatic origin (primary tumor or metastasis)
- •oIf only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the pancreas
- •oDeemed non-resectable at a multidisciplinary conference
- •Candidate to standard systemic therapy, defined as one of
- •oGemcitabine monotherapy,
- •oGemcitabine and nab-paclitaxel combination,
- •oGemcitabine and capecitabine combination,
- •o5-fluorouracil, oxaliplatin and irinotecan combination (FOLFIRINOX), or
- •oNew standard treatments approved by the multidisciplinary cancer group ‘Dansk Pancreas Cancer Gruppe’ in the inclusion period.
- •Measurable disease according to RECIST 1.1
- •ECOG performance status 0-2
- •Age at least 18 years
- •Adequate bone marrow, liver and renal function allowing systemic chemotherapy
- •oAbsolute neutrophil count =1.5x10^9/l and thrombocytes = 100x10^9/l
- •oBilirubin = 3 x upper normal value and alanine aminotransferase = 5 x upper normal value
- •oCalculated or measured renal glomerular filtration rate at least 30 mL/min
- •Contraception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject’s male partner or hormonal contraceptive are acceptable
- •Written and orally 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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Potentially resectable disease
- •Incapacity, frailty, disability, or comorbidity to a degree that according to the investigator is not compatible with participation in the protocol
- •Other active malignant disease requiring therapy
- •Other systemic anti-cancer therapy (palliative radiotherapy is allowed)
- •Pregnant (positive pregnancy test) or breast feeding women
研究者
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