A Pilot Study of Teng-Long-Bu-Zhong-Tang Based Herbal Therapy in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
Teng-Long-Bu-Zhong-Tang (TLBZT) is a modern anti-cancer herbal formula. Experimental studies have confirmed the anti-cancer potential of TLBZT against colorectal cancer. This trial will evaluate the safety and efficacy of TLBZT based herbal therapy in combination with chemotherapy in patients with metastatic colorectal cancer.
详细描述
A phase I/II, multicentric,randomized, controlled clinical trial.
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
- 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 adenocarcinoma of the colon or rectum with non-resectable metastatic disease;
- •Ages between 18 and 70 years;
- •Measurable lesion;
- •Karnofsky Performance Status ≥ 60%;
- •Estimated life expectancy of at least 6 months;
- •Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥90g/L, N > 1.5×10^9/L, platelet≥ 100×10^9/L, normal liver and kidney function;
- •Informed consent from the patient.
排除标准
- •Symptomatic brain metastasis;
- •Adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
- •Serious disease of heart, liver, kidney with severe dysfunction;
- •Serious complications, such as gastrointestinal tract obstruction and hemorrhage;
- •Pregnancy or breast-feeding women;
- •Mental or cognitive disorders;
- •Be participating other drug trials;
- •Who are allergic to the study drug.
研究组 & 干预措施
chemotherapy
Patients receive chemotherapy until disease progression or unacceptable toxicity
干预措施: Chemotherapy (Drug)
Herbal therapy plus chemotherapy
Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity
干预措施: Chemotherapy (Drug)
Herbal therapy plus chemotherapy
Patients receive herbal therapy plus chemotherapy until disease progression or unacceptable toxicity
干预措施: Herbal therapy (Drug)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: 2 months
次要结局
- Adverse events(1 month)
- Overall Survival (OS)(2 months)
- Symptoms(2 months)