EUCTR2019-000793-27-IT进行中（未招募）1 期
A phase II study on adjuvant Vaccination with dendritic cells loaded with autologous tumor homogenate in resected stage IV rare cancers: Head&Neck (H&N), neuroendocrine Tumors (NET) and soft tissue sarcoma (STS). - RaC-Ad
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 个研究点目标入组 51 人开始时间: 2021年5月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 51
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 rare cancers: Head&Neck Squamous Cell Carcinoma (HNSCC), Neuroendocrine Tumors (NET) and Soft Tissue Sarcoma (STS), 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, candidates for only observation as per clinical practice (no standard treatment is available after surgery).
- •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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable.
- •Patient who completed surgery more than 90 days before study enrolment.
研究者
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