Personalised Therapy for Patients With Metastatic Adenocarcinoma of the Pancreas Determined by Genetic Testing and Avatar Model Generation
试验速览
- 阶段
- 2 期
- 入组人数
- 146
- 试验地点
- 5
- 主要终点
- 1-year overall survival
研究概览
简要总结
This is a multicenter, open label, randomised phase II clinical trial for patients with metastatic adenocarcinoma of the pancreas. Patients randomised to the experimental arm will undergone tumoral biopsy before starting first line of treatment and will be administered personalised therapy as second or third line.
详细描述
This is a multicenter, open label, randomised phase II clinical trial for patients with metastatic adenocarcinoma of the pancreas.
Patients with metastatic disease will be randomised to the experimental or control arms. Those in the experimental arm will undergone a tumoral biopsy in order to perform exome sequencing, bioinformatic report, and avatar mouse models for drug testing. This information will allow the expertise panel to elaborate a treatment recommendation as second or third lines of treatment. Patients in the control arm will receive treatment as per investigator´s judge. The main objective of the trial is to determine whether personalised treatments achieve improved 1-year overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas.
- •ECOG performance status 0 or 1
- •Age ≥ 18 years old.
- •Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study.
- •One or more sites of metastasis with one of the susceptible of biopsy.
- •Measurable or evaluable disease
- •No prior treatment with radiotherapy, surgery, chemotherapy or investigational treatment for the metastatic disease or no more than the three cycles of first line chemotherapy. Palliative radiotherapy for bone metastasis is allowed. Adjuvant or neoadjuvant radiotherapy or chemotherapy are allowed if they finished more that 6 months ago and the patient has no remaining toxicities.
- •Bone marrow function as follows, no more than 14 days prior to randomisation:
- •ANC > 1,500 cells/mm3 Platelets > 100,000 cells/mm3 Hemoglobin ≥9 g/dl
- •Adequate liver, renal and bone marrow functions.
- •AST (SGOT), ALT (SGPT) ≤ 2.5 × ULN and ≤ 5 x ULN if liver metastases.
- •Bilirubin ≤ 1,5 x ULN
- •Albumin total ≥ 0,75 ULN
- •Creatinine ≤ 1,5 x ULN
- •Ability to sign informed consent
- •Patients will be allowed to be randomised just once.
排除标准
- •Brain metastases, unless they have been previously treated and stable for 3 months at least (defined as no oedema, no need of steroids and stable disease in two CT scans separated by a minimum of 4 weeks).
- •Locally advanced disease.
- •Malignancies other than pancreatic cancer diagnosed within 5 years prior to randomization, except for adequately treated carcinoma in situ or basal or squamous cell skin cancer.
- •Bacterial, viral or fungal active infection that require systemic treatment.
- •Any contraindication for tumor biopsy.
- •Past or present HIV or hepatitis B or C infection.
- •Severe medical problems affecting organs or psychiatric illnesses that could interfere with the safety of the patient in the trial.
- •Pregnancy or breastfeeding women.
- •Patient will need to be informed and agree to undergo tumoral biopsy in the experimental arm.
研究组 & 干预措施
Experimental arm
Personalised treatment will be chosen for patients based on the results of tumor sequencing, bioinformatics and avatar model drug testing.
干预措施: Personalised treatment (Drug)
Control
Investigators are allowed to chose the best option of standard treatment for patients.
干预措施: Treatment chosen per investigator´s judge (Drug)
结局指标
主要结局
1-year overall survival
时间窗: 1-year overall survival
Efficacy. 1-year overall survival
次要结局
未报告次要终点