Patient-reported Outcome-based Surveillance System Evaluating Safety and Efficacy of Preoperative Immunochemotherapy +/- Chemoradiation in Patients With Esophageal Squamous Cell Carcinoma - A Prospective, Explorative, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pathologic complete response rate
研究概览
简要总结
Preoperative Immune checkpoint inhibitors combined with chemotherapy have revolutionized the treatment landscape of locally advanced esophageal squamous cell carcinoma. However, there are still a significant proportion of patients who could not benefit from such treatment modality. Currently, no effective biomarkers were identified to stratify responders and non-responders. Early dynamic and persistent relief of dysphagia may act as a predictive biomarker to reflect the on-treatment anti-tumor activity. In this prospective study, we aimed to explore the feasibility of using patient-reported outcomes (PROs) to predict the pathological complete response of esophageal squamous cell carcinoma patients treated with neoadjuvant immunochemotherapy with or without short-term radiation as well as to assess the efficacy and safety of short-term radiotherapy in PROs-insensitive patients after one cycle of neoadjuvant 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed esophageal squamous cell carcinoma
- •Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4aN1-2M0, cT3-T4aN0M0)
- •Treatment-naive
- •Expected life span > 6 months
- •Aged 18 - 75 years old
- •Adequate organ functions
- •Participants are fully informed about the whole study and are willing to sign the informed consent
排除标准
- •Previous history of thoracic surgery or radiation
- •Cervical or multi-origin esophageal cancer
- •Known or suspected experimental drug allergy
- •Pregnant or lactating women
- •Esophagomediastianl fistula
- •Peripheral neuropathy
- •Previous cancer history other than esophageal cancer
- •Severe organ function deterioration that can not tolerate neoadjuvant therapy
- •Previous autoimmune diseases
- •diabetic history > 10 years
- •interstitial pulmonary disease, non-infectious pulmonitis
- •Active type B hepatitis
- •Any other conditions that may affect patients' safety and compliance
研究组 & 干预措施
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
干预措施: Esophagectomy (Procedure)
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
干预措施: Paclitaxel-albumin (Drug)
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
干预措施: Cisplatin (Drug)
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
干预措施: Carboplatin (Drug)
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
干预措施: Tislelizumab (Drug)
Neoadjuvant immunochemotherapy +/- short-term radiotherapy
Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy
干预措施: VMAT or IMRT (Radiation)
结局指标
主要结局
Pathologic complete response rate
时间窗: Three to five working days after surgery
The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery
次要结局
- Objective Response Rate (ORR)(Up to 24 weeks)
- Safety as measured by number of participants with Grade 3 and 4 adverse events(Up to 12 weeks)
- Overall survival(From the date of diagnosis to the date of death, assessed up to 100 months)
- Event-free survival(From the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months)
- R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resction rate(Three to five working days after surgery)
- Major pathological response(Three to five working days after surgery)
- Dysphagia relief score(score calculated by EORTC OES-18 dysphagia scale criteria at each cycle up to 6 months)