EUCTR2015-000894-11-IT进行中（未招募）1 期
Vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer: a phase II study - COREVAX-1
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 个研究点目标入组 19 人开始时间: 2017年12月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 19
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
- •- Histologically confirmed stage IV colorectal cancer surgically treated with radical intent. - The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab of IRST IRCCS and must fulfil all the acceptance criteria prescribed by the GMP procedures. - The patient must be disease-free. - Age >18 years. - ECOG performance status 0 or 1. - Acceptable organ function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Residual disease after surgery. - Relapse within 6 months since primary treatment of stage I-III colorectal cancer. - Surgery more than 60 days before study enrolment. - History of other neoplastic diseases. - History of congenital or acquired immunodeficiency. - Any positivity for the serologic markers of HBV (including at least anti-HBs antibodies and anti-HBc antibodies), HCV, HIV or Treponema pallidum. - Pregnancy or nursing. - Patients undergone surgery after preoperatory chemotherapy with a fluoropyrimidine plus oxaliplatin, unless they are not candidate for postoperatory chemotherapy with the same schedule in the opinion of the Investigator (e.g. for unacceptable toxicity) or refuse completion of the perioperatory treatment. - Participation in another clinical trial. - Any active inflammatory or autoimmune disease. - Any contraindication to leukaphaeresis.
研究者
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