JPRN-jRCT2080224571已完成2 期
Phase II trial of the combination of SPM-011 and BNCT System (BNCT30) for unresectable locally recurrent HNSCC or unresectable HNNSCC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
研究概览
简要总结
In 21 patients with local recurrent head and neck squamous cell carcinoma or head and neck non-squamous cell carcinoma, the response rate of 90 days after BNCT was 71.4% and the complete response rate was 23.8%. The overall survival rate (730 days after BNCT) was 85.2%.
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) Document consent by his/her own free will
- •(2) 20 years old or older
- •(3) 60% of Karnofsky Performance Status (KPS) or higher
- •(4) The primary lesion is histologically head and neck cancer
- •(5) At least one measureable lesion in the target lesion site based on RECIST (version 1.1)
- •(6) Prior radiation therapy satisfying one of the following conditions:
- •(6) Prior radiation therapy satisfying one of the following conditions:
- •For locally recurrent squamous cell carcinoma:
- •- Radiation therapy, fractionation around 2Gy/day, total dose within the range of 40 - 75 Gy
- •For non-squamous cell carcinoma:
- •- No prior radiation therapy
- •- Radiation therapy, not more than 75 Gy of total biologically effective dose
- •(7) 90 days or more have passed since the last irradiation date of prior radiation therapy for the evaluation target lesion site to the scheduled date of BNCT, except for non-squamous cell carcinoma with no history of prior radiation therapy
- •(8) Over 90 days of survival is expected after BNCT.
- •(9) Non problematic disorder (Screening test)
排除标准
- •(1) Active multiple primary cancers
- •(2) Distant metastasis
- •(3) Active infections requiring systemic treatment
- •(4) Serious Complications
研究者
相似试验
Unknown
2 期
A Study of SBRT for Squamous Cell Carcinoma of the Head and NeckHead and Neck NeoplasmsSquamous Skin CarcinomaSquamous Cell CarcinomaNCT04435938McMaster University38
撤回
1 期
QUILT-3.047: NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 TherapyHead and Neck Squamous Cell CarcinomaNCT03169764ImmunityBio, Inc.
终止
2 期
Pembrolizumab in HNSCC With Residual Disease After RadiationHead and Neck Squamous Cell CarcinomaNCT02892201Yale University9
终止
2 期
Paclitaxel vs Paclitaxel + Cetuximab in Recurrent - Metastatic Head & Neck Carcinoma After Failure of a 1º ChemotherapyHead and Neck CancerNCT03887442Grupo Español de Tratamiento de Tumores de Cabeza y Cuello17
招募中
2 期
Tirelizumab in Combination With Carboplatin and Albumin-binding Paclitaxel for Neoadjuvant Therapy in HNSCCHead and Neck Squamous Cell CarcinomaOral CancerNCT05941338Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University100