An Open Label Phase 2 Study of Total Neoadjuvant Therapy (TNT) Consisting of FLOT With Pembrolizumab and Short Radiation for Patients With Locally Advanced Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 3-year event-free survival (EFS) rate
研究概览
简要总结
This study is to evaluate the effectiveness of treatment for esophagogastric junction carcinoma, total neoadjuvant therapy (TNT) including pembrolizumab and FLOT is conducted, aiming to choose between surgery or organ preservation treatment strategies.
详细描述
In Immunochemotherapy before short-term radiation therapy, pembrolizumab 200mg will be intravenously infused at 21-day intervals for 2 doses. FLOT (docetaxel 50 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200mg/m2, 5-FU 2600 mg/m2) will be intravenously infused at 14-day intervals for 2 doses.
Regarding short-term radiotherapy, irradiation will be delivered from day1 to day5, with a dose of 5 Gy per fraction for a total of 25 Gy.
In Immunochemotherapy after short-term radiation therapy, pembrolizumab 200mg will be intravenously infused on day 8. FLOT will be intravenously infused on day 1 and day15.
If CR or Near CR is achieved after the first and second efficacy assessment, pembrolizumab 200mg will be intravenously infused at 21-day intervals for 14 doses and FLOT will be intravenously infused at 14-day intervals for 4 doses as immunochemotherapy as non-operative management (NOM).
If CR or Near CR is not achieved after the first or second efficacy assessment, surgery will be performed. And then pembrolizumab 200mg will be intravenously infused at 21-day intervals for 14 doses and FLOT will be intravenously infused at 14-day intervals for 4 doses as Postoperative adjuvant immunochemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pembrolizumab plus FLOT, Ratiation
干预措施: Oxaliplatin (Drug)
Pembrolizumab plus FLOT, Ratiation
干预措施: Levofolinate (Drug)
Pembrolizumab plus FLOT, Ratiation
干预措施: Fluorouracil (5-FU) (Drug)
Pembrolizumab plus FLOT, Ratiation
干预措施: Radiation Therapy (Radiation)
Pembrolizumab plus FLOT, Ratiation
干预措施: Pembrolizumab (Drug)
Pembrolizumab plus FLOT, Ratiation
干预措施: Docetaxel (Drug)
结局指标
主要结局
3-year event-free survival (EFS) rate
时间窗: 3 years
次要结局
- Organ-sparing survival(3 years)
- Overall survival (OS)(3 years)
- Clinical response rate(3 years)
- Clinical complete response rate(3 years)
- Major pathological response rate (MPR rate)(3 years)
- Pathological complete response rate (pCR rate)(3 years)
- R0 resection rate (R0 rate)(3 years)
- TNT completion rate(3 years)
- Treatment completion rate(3 years)
- Adverse event incidence rate(3 years)
- Post-treatment ctDNA clearance(3 years)
- EORTC QLQ-C30(3 years)
- EORTC QLQ-OG25(3 years)
研究者
Kohei Shitara
Chief of Gastroenterology and Gastrointestinal Oncology Division
National Cancer Center Hospital East