Clinical Outcomes of Treatment With Immunomodulator Plus Standard Anti-cancer Therapies for Patients With Colorectal Cancer: A Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Colorectal cancer (CRC) is the third most common cancer worldwide. Despite the availability of numerous standard therapies for CRC, clinical outcomes from these treatments remain unsatisfactory. The tumor microenvironment (TME) plays an important role to regulate tumor growth, progression, and metastasis and can limit the efficacy of cancer therapies. Therefore, targeting TME would be an efficient approach for cancer treatment. Astragalus polysaccharide (APS) Injection is an immunomodulator, which can enhance anti-tumor efficacy through regulation of TME. This drug has been approved as a prescription drug for alleviating cancer-related fatigue by the Taiwan Food and Drug Administration (TFDA). In this real-world study, clinical data will be collected both retrospectively and prospectively from the medical records of CRC patients undergoing anti-cancer treatment who did or did not receive immunomodulators. It can be used to understand the possible clinical benefit of immunomodulator plus anti-cancer therapies for patients with CRC, and physicians can refer to these results to give patients the suitable treatment recommendations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20 years and older
- •Patients who have been given a diagnosis of colorectal cancer
- •Patients had previously initiated anti-cancer therapies between Jan 01 2025 and Dec 31, 2027
排除标准
- 未提供
研究组 & 干预措施
Treatment
Immunomodulator (APS Injection) plus standard anti-cancer therapies
Control
Standard anti-cancer therapies
结局指标
主要结局
Overall survival
时间窗: From the earliest record until Dec 2030
次要结局
- Disease free survival(From the earliest record until Dec 2030)
- Distant metastasis free survival(From the earliest record until Dec 2030)
- Progress free survival(From the earliest record until Dec 2030)
- Hematological lab data change(Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).)
- Weight loss(Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).)
- Common Terminology Criteria for Adverse Events (CTCAE) Toxicities(Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).)
- Fatigue score change(Baseline, throughout treatment (assessed at each treatment cycle), and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).)
- Tumor response(Baseline and at the End of Treatment (until treatment discontinuation, up to study completion [anticipated December 2030]).)
研究者
Chou-Chen Chen
Attending Physician
Cheng Ching Hospital