NCT03821870已完成不适用
Predictive Value of In-vitro Anti-cancer Therapy Sensitivity Testing on Tumoroids From Patients With Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Predictive value of in-vitro testing
研究概览
简要总结
It will be investigated whether it is possible to predict the effect or lack of effect of first-line treatment by analysing cancer cells from the individual patient receiving standard first line treatment. Also, the feasibility of selecting second-line therapy based on pre-treatment biopsies will be investigated.
Cells from pancreatic cancer will be grown in the laboratory to form small, circulating tumors and adjacent tissue, so called tumoroids. The tumoroids will then be exposed to different pre-specified anticancer drugs to hopefully reveal sensitivity or lack of sensitivity in the specific patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-resectable pancreatic cancer
- •Biopsy proven adenocarcinoma compatible with pancreatic origin (primary tumor or metastasis)
- •If only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the pancreas
- •Deemed non-resectable at a multidisciplinary conference
- •Candidate to standard systemic therapy, defined as one of
- •Gemcitabine monotherapy,
- •Gemcitabine and nab-paclitaxel combination,
- •Gemcitabine and capecitabine combination,
- •5-fluorouracil, oxaliplatin and irinotecan combination (FOLFIRINOX), or
- •New standard treatments approved by the multidisciplinary cancer group 'Danish Pancreatic Cancer Group' 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
- •Absolute neutrophil count ≥1.5x10^9/l and thrombocytes ≥ 100x10^9/l
- •Bilirubin ≤ 3 x upper normal value and alanine aminotransferase ≤ 5 x upper normal value
- •Calculated 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
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
研究组 & 干预措施
Standard treatment
Standard first line treatment
干预措施: Inditreat (Diagnostic Test)
Standard treatment
Standard first line treatment
干预措施: Experimental drug (Drug)
结局指标
主要结局
Predictive value of in-vitro testing
时间窗: 2 months
Predictive value is defined as the ability to correctly predict response or resistance to first-line chemotherapy
次要结局
- Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by treatment response (RESIST 1.1 criteria)(Every 2 months during treatment up to 180 days)
- Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by progression free survival (PFS)(Every 2 months up to 12 months)
研究者
研究点 (1)
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