A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Overall response rate of the treatment
研究概览
简要总结
The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer, which involves chemoradiotherapy after induction chemotherapy. The main questions it aims to answer are:
- Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate?
- Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival? Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer.
Participants will:
- Receive induction chemotherapy for 4 to 8 cycles, followed by chemoradiation therapy if downstage to T3
- Visit the clinic once every week for checkups and tests
- Keep a diary of their symptoms
详细描述
The treatment of T4-stage esophageal cancer is challenging because of a high esophageal perforation rate (19%) after concurrent chemoradiotherapy. This research aims to investigate whether a novel sequential chemoradiotherapy approach can improve the treatment response rate and reduce the incidence of esophageal perforation in participants with T4-stage esophageal cancer. The proposed novel treatment strategy involves induction chemotherapy for 4 to 8 cycles. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy. The study will be conducted in two phases, starting with a phase I study to determine safety, followed by a phase II study to evaluate overall efficacy. Expected outcomes include improved treatment response rates and reduced esophageal perforation rates in T4-stage esophageal cancer, offering a better treatment option for these patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed esophageal squamous cell carcinoma
- •Tumor or lymph nodes invade adjacent organs (T4 stage)
- •Aged between 18-70 years old
- •Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) <2
- •Hemoglobin ≥ 10 g/L, absolute neutrophil count ≥ 2×10^3/L, platelet count ≥ 100×10^9/L, total bilirubin ≤ 1.5 mg/L, serum transaminases ≤ 105 U/L, creatinine clearance ≥ 40 mL/min.
排除标准
- •Previous chemotherapy history
- •Myocardial infarction within the last three months
- •History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema
- •Has other malignancies currently
- •Uncontrolled infection
- •Pregnancy or lactation
- •Perforated esophagus at the time of diagnosis
结局指标
主要结局
Overall response rate of the treatment
时间窗: At week 8, week 16, and 4 weeks after completion of concurrent chemoradiotherapy (CCRT).
Overall response rate = complete response (CR) rate + partial response (PR) rate.
Duration of response (DOR)
时间窗: At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.
Defined as the time from CR or PR to the time of disease progression or death.
次要结局
- Adverse events of treatment(During treatment (up to 24 weeks))
- Progression-free survival(At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.)
- Overall survival time(At week 8, week 16, and 4 weeks after completion of CCRT. Thereafter, every 3 months.)
- Esophageal perforation rate(At week 8, week 16, and 4 weeks after completion of CCRT. And at anytime when participants suffer from symptoms in suspicious of esophageal perforation, eg. chest pain, hemoptysis, and fever.)