Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Prevalence and severity of adverse symptoms
研究概览
简要总结
Immunotherapy shows satisfactory effectiveness and safety in patients with esophageal cancer. Immunotherapy-based regimens have a better survival benefit compared to previous chemotherapy and radiotherapy. Patient-reported outcomes (PRO) provide a reliable assessment of patients' functional status during treatment. However, the spectrum of symptoms in esophageal cancer patients receiving immunotherapy is uncertain, and there are no studies applying the symptom bank based on PRO to the immunotherapy model for esophageal cancer. In this prospective study, the investigators aimed to preliminarily screen for symptoms associated with immunotherapy for esophageal cancer through a systematic literature review and expert evaluation, and build a symptom item bank for esophageal cancer patients receiving immunotherapy. Adverse symptoms in esophageal cancer patients treated with immunotherapy were collected prospectively. The distribution and severity of the symptoms, as well as the trajectory of symptom change were further analyzed to demonstrate the validity and reliability of the symptom item bank. It would refine the spectrum of symptoms for esophageal cancer patients receiving immunotherapy and provide a foundation for assessing the specific symptom burden in patients with esophageal cancer receiving immunotherapy regimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 resectable, locally advanced, advanced metastatic esophageal cancer
- •Having received or undergoing an immunotherapy-based treatment regimen
- •Age 18-75 years
- •ECOG PS of 0-2
- •Adequate organ function
- •Life expectancy > 6 months
- •Participants are fully informed about the whole study and are willing to sign the informed consent
排除标准
- •Absence of immunotherapy regimen, or recieving radiotherapy.
- •Presence of primary tumours elsewhere, such as gastric cancer, lung cancer or cervical cancer
- •Severe organ function deterioration and intolerance to immunotherapy
- •Pregnant or breast-feeding women
- •Previous autoimmune disease
- •Any other conditions that may affect patients' safety and compliance
- •Psychological, family, social and other factors leading to inability to inform consent
结局指标
主要结局
Prevalence and severity of adverse symptoms
时间窗: Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months.
Incidence and severity of adverse symptoms in esophageal cancer patients treated with immunotherapy
次要结局
- Trajectory of adverse symptoms(Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months.)
研究者
GuiBin Qiao
Professor of Medicine
Guangdong Provincial People's Hospital