JPRN-jRCTs061180058已完成1 期
A phase I study of combination immunotherapy with HSP70 derived peptide, GPC3 derived peptide, IMP321 and Hiltonol for patients with advanced or metastatic solid cancer - A phase I study of combination immunotherapy with HSP70 derived peptide, GPC3 derived peptide, IMP321 and Hiltonol for patients with advanced or metastatic solid cancer
agano Hiroaki0 个研究点目标入组 17 人开始时间: 2019年3月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
研究概览
简要总结
This phase I study evaluated the safety, peptide-specific CTL, and antitumor effects of a novel vaccination therapy comprising multi-HLA-binding HSP70/GPC3 peptides and adjuvants of LAG-3Ig and Poly-ICLC against gastrointestinal cancers. Seventeen patients received therapy without DLT. Peptide-specific CTL induction by HSP70 and GPC3 proteins was observed in 11 and 13 cases. Tumor markers were decreased in 10 cases. This novel peptide vaccination therapy was safe and effective for patients with GI cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.patients with advanced or metastatic solid cancer (Pancreatic cancer, colon cancer, gastric cancer, esophageal cancer, liver cancer and breast cancer) proven by histology or imaging (CT or MRI)
- •2. Patients with HLA-A*2402 -A*0201 -A*0206
- •3. Standard treatment failure cancer
- •4. Age; 20>=
- •5. Performance Status (PS); 0-1, Eastern Cooperative
- •Oncology Group (ECOG)
- •6. Preserved organ functions (number of WBCs more than
- •2.0x103/mm3; % of lymphocyte >=15; number of platelets
- •>=7.5x103/mm3; hemoglobin >=8.0 g/ dl; creatinine <=2.5
- •times of upper normal limit)
- •7.Patients provided written, informed consent to participate
排除标准
- •The exclusion criteria were, double cancer, pneumonitis, severe allergy, severe infection, neurological disturbance, uncontrolled general diseases, heart diseases, general steroid treatment, or any prior therapies using same agents of this study.
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