Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Effect of 5-year survival rate of Ganoderma osteosarcoma patients
研究概览
简要总结
Osteosarcoma is the most common primary highly malignant bone tumor in children and young people. Incidence rates are bimodal, with the first peak occurring in adolescence and the second peak in patients over 60 years of age. The 5-year survival rate of patients with osteosarcoma is less than 20%. This study aims to improve the prognosis of patients and change the outcome of patients with osteosarcoma.
详细描述
This project intends to conduct a multicenter, randomized, double-blind, parallel-controlled clinical trial of ganoderma spore powder and doxorubicin combined with cisplatin chemotherapy in the treatment of osteosarcoma patients. The combination therapy of traditional chemotherapeutics has not played a good effect and has large side effects. The Ganoderma lucidum spore powder group is a natural botanical drug that has a good anti-tumor auxiliary effect in regulating the tumor immune microenvironment. The investigators' previous research showed that Ganoderma lucidum spore powder can inhibit the growth and metastasis of osteosarcoma in the body without obvious toxic and side effects, which indicates that this research scheme has strong feasibility.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •Clinical diagnosis of osteosarcoma
- •Must be able to swallow tablets
- •after surgical resection
排除标准
- •Symptomatic central nervous system metastases and/or carcinomatous meningitis Known HIV or active hepatitis B/C infection
- •Active infection requiring systemic treatment
- •Clinically significant cardiac arrhythmias
- •Class III or IV Congestive Heart Failure as defined by the New York Heart
- •Association functional classification system < 6 months prior to screening
- •A pregnant or nursing female, or women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- •Any condition for which participation would not be in the best interest of the participant
- •Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements
- •Patients participating in another clinical investigation at the time of signature of the informed consent
研究组 & 干预措施
sham group
Treated with conventional chemotherapy drugs
干预措施: Chemotherapy (Drug)
NC group
Treated with conventional chemotherapy drugs and Placebo
干预措施: Chemotherapy (Drug)
NC group
Treated with conventional chemotherapy drugs and Placebo
干预措施: Placebos (Drug)
experimental group
Treated with conventional chemotherapy drugs and Ganoderma lucidum
干预措施: Ganoderma lucidum (Drug)
experimental group
Treated with conventional chemotherapy drugs and Ganoderma lucidum
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Effect of 5-year survival rate of Ganoderma osteosarcoma patients
时间窗: up to 60 months
Karnofsky (Karlfeld, KPS, percentile) functional status scoring criteria
次要结局
未报告次要终点