Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Liver Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Relief degree of tumors
研究概览
简要总结
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable liver cancer.
详细描述
By enrolling patients with unresectable liver cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
- •Body tumor 1-6, with at least one tumor length > 2 cm
- •KPS ≥ 70, lifespan > 6 months
- •Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
排除标准
- •Patients with cardiac pacemaker
- •Patients with brain metastasis
- •Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
研究组 & 干预措施
Cancer ablation
In this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: Cancer ablation (Device)
Life information rehabilitation therapy
In this group, the patients will drink "Qilisheng" Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: Life information rehabilitation therapy (Drug)
Combination therapy
In this group, the patients will receive the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (> 2 cm), then "Qilisheng" Immunoregulatory Oral Solution will be provided for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: Cancer ablation (Device)
Combination therapy
In this group, the patients will receive the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (> 2 cm), then "Qilisheng" Immunoregulatory Oral Solution will be provided for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: Life information rehabilitation therapy (Drug)
结局指标
主要结局
Relief degree of tumors
时间窗: 3 months
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
次要结局
- Overall survival（OS）(3 years)
- Progress free survival（PFS）(1 year)