PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Fatigue by the Brief Fatigue Inventory-Taiwanese Form
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of PG2 concurrent with concurrent chemoradiation therapy (CCRT) for relieving fatigue among locally advanced esophageal cancer patients who are under preoperative chemoradiation therapy at curative setting. This study will be designed to compare the fatigue status between two study arms patients under CCRT.
The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Also, the investigators try to determine the effect of PG2 on tumor response post CCRT, disease free survival (DFS) and overall survival (OS) of patients by comparing the above outcome between the two study arms.
The mechanism of immunomodulatory of PG2 and tumor response, DFS and OS for patients with esophageal cancer treated with preoperative CCRT concurrent with or without PG2 will be investigated in add-on study.
详细描述
It's randomized, open-label study. Locally advanced esophageal cancer patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. The eligible patients will be randomized into one of two study arms: 1) the CCRT- PG2 arm; and 2) the CCRT alone arm. All eligible patients will receive the standard preoperative CCRT during study period and standard surgery 6 weeks after completion of radiation therapy.
The primary objective of this study is to evaluate the efficacy of PG2 concurrent with CCRT for relieving fatigue. Patient's fatigue status will be measured by the BFI-T.
The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Patients' quality of life will be assessed by the Functional Assessment of Cancer Therapy- General (FACT-G7 v.4). Patients' appetite will be assessed by VAS appetite score. The effect of PG2 on tumor response post CCRT, DFS and OS of patients will also be evaluated.
Peripheral blood samples and tumor biopsy samples will be collected from all subjects at screening period, during CCRT and post CCRT period to perform Immune biomarker assessment in the add-on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who signed the informed consent form;
- •The age of eligible patients should be 20-75 years old;
- •Performance status of ECOG 0-1 at time of screening;
- •Have Esophageal and esophagogastric junction cancer (non-cervical esophagus);
- •Have stage IIB-IIIB locally advanced carcinoma of esophagus;
- •Pathologically confirmed primary squamous cell carcinoma of the esophagus;
- •Patient must be willing and able to complete fatigue and quality of life questionnaires.
排除标准
- •BFI > 7 at time of screening;
- •Concomitant malignancy or prior invasive malignancy unless disease free for a minimum of 2 years;
- •Medical contraindications to esophagectomy;
- •Female patients are pregnant or breast-feeding;
- •Have inadequate bone marrow, liver, and renal function
- •Uncontrolled systemic disease
- •Regular steroid use as determined by investigators;
- •Patients take central nervous system stimulators such as Methylphenidate within 30 days before screening;
- •Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening.
- •BMI < 16
- •Nutrition status SGA rating C.
研究组 & 干预措施
CCRT-PG2 arm
Astragalus Polysaccharides 500 mg
干预措施: Astragalus Polysaccharides 500 mg (Drug)
结局指标
主要结局
Fatigue by the Brief Fatigue Inventory-Taiwanese Form
时间窗: Through 12 weeks
The Brief Fatigue Inventory (BFI) has been shown to have good reliability of fatigue measurement. This instrument consists of a one-page fatigue assessment tool that contains nine items, each measuring the severity of fatigue on a 0-through-10 scale. The first three items assess current level of fatigue, and worst and usual fatigue in the preceding 24 hours. Six items assess the extent to which fatigue has interfered with different aspects of life, such as work or social relations, during the preceding 24 hours. The BFI score is calculated from the mean of completed items.
次要结局
- Quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G7 v.4)(Through 12 weeks)
- Visual Analog Score for appetite(Through 12 weeks)
- Tumor response be evaluated by RECIST 1.1, irRECIST and Pathological response.(Week 11 and Week 12)
- The change of of biomarkers (inhibitory immune factors, dendritic cells makers, tumor-associated macrophages, immune-regulatory markers and oncogenic-mediated immune markers) will be combined to report the immune profile.(Through 12 weeks)
- Disease free survival(2 years after the take-off day of the last patient)
- Overall survival in locally advanced esophageal cancer patients with PG2 treatment under preoperative chemoradiation therapy(2 years after the take-off day of the last patient)