Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 主要终点
- Incidence of participants with clinically definite Sorafenib-related Hand Foot Syndrome
研究概览
简要总结
Hepatocellular carcinoma (HCC) is a common fatal malignant tumor, although with the popularity of health examination, most patients were diagnosed as HCC in advanced stages so far. Sorafenib is currently recognized worldwide as the only effective treatment for advanced HCC. However, sorafenib need long-term medication, and will bring a series of side effects, including, hand, foot and comprehensive syndrome (Hand-foot syndrome, HFS) limbs swelling, rash, peeling, pain.Occurrence rate of HFS is about 21%-51%, which seriously affect patient's quality of life.Besides, this side effects appeared to be dose-related.When severe HFS happened, sorafenib need to reduce dosage or discontinue administration, which could seriously affect the patient's survival. Therefore, investigators designed this prospective randomized controlled study to explore preventive effect of celecoxib for sorafenib related HFS, the influence on the quality of life in patients with, and also the synergistic anti-tumor effect of celecoxib in combination with sorafenib on HCC. This study will explore horizon of improving treatment for sorafenib in patients with advanced HCC,quality of life and tumor control.
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
- •1.Diagnosed with HCC according to the Primary liver cancer diagnosis and treatment practices published by the Ministry of Health in 2011 China
- •2.A Karnofsky Performance Status (KPS) score ≥70 points
- •3.Age between 18 and 70 years
- •4.Child-Pugh classA or B (class B patients had scores no greater than 7 points). In addition, the baseline laboratory tests had to meet the following criteria: white blood cells (WBCs) ≥1.5 × 109/L, platelets ≥50 × 109/L, hemoglobin ≥80 g/L, serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 x the upper limit of normal (ULN), serum creatinine ≤ 1.5 x ULN, an international normalized ratio (INR)<1.5 or prothrombin time < the ULN + 4 seconds, albumin ≥30 g/L, and total bilirubin ≤34mmol/L
- •5.Patients with advanced hepatocellular carcinoma who failed first-line therapy with surgery，radiofrequency ablation
排除标准
- •1.Pugh Child-Pugh Grade C, or with massive ascites or had a history of hepatic encephalopathy, or previous history of gastrointestinal bleeding
- •2.Poor general condition or cachexia
研究组 & 干预措施
Celecoxib group
Patients were treated with sorafenib taking capsules celecoxib (Celebrex) at the same time, 200mg/day, last 6 months
干预措施: Celecoxib (Drug)
Celecoxib group
Patients were treated with sorafenib taking capsules celecoxib (Celebrex) at the same time, 200mg/day, last 6 months
干预措施: Sorafenib (Drug)
Control group
Patients take sorafenib only.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Incidence of participants with clinically definite Sorafenib-related Hand Foot Syndrome
时间窗: within the first 6 months after sorafenib administration
次要结局
- Overall survival(one year)
研究者
Zhongguo Zhou
Associate Professor
Sun Yat-sen University