Multicenter, Open-labeled, Controlled Phase II Study: Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Treatment options for advanced hepatocellular carcinoma (HCC) are limited due to patients' poor condition, advanced tumor, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) or Trans-catheter chemo-embolization (TACE) is the most widely used locoregional treatment for advanced HCC. But no solid evidences support the beneficial effect of the chemotherapy in TACE. Many advanced HCC patients also can't tolerate the locoregional chemotherapy. The p53 gene has multiple anticancer functions and does not have any of the immune-inhibitory effects of chemo- or radio-therapy. The objectives of this study are to investigate the efficacy and safety usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC.
详细描述
Study design: multicenter, open-labeled, active-controlled phase II study
Study treatments: TACE combined with rAd-p53 injection vs.TACE. The treatments are given once per 21 days until the disease progression. For the experiment group, 2 X 1000,000,000,000 viral particles of rAd-p53 will be injected into the embolization artery.
Study objectives: efficacy and safety of the study treatments
Study endpoints: safety (adverse events, vital signs, lab tests, ECG and physical examination) and efficacy (progression-free survival, overall survival, and ECOG PS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histopathologically diagnosed HCC;
- •unresectable;
- •over 18 years old;
- •with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- •with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C;
- •with Child-Pugh score A or B;
- •with normal tests of hemogram, blood coagulation, liver and kidney function;
- •signed the informed consent form.
排除标准
- •Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
- •have serious heart, lung function abnormalities or severe diabetes patients;
- •active infection;
- •liver function Child-Pugh grade C;
- •secondary and diffuse hepatocellular carcinoma patients;
- •extensive metastasis;
- •severe atherosclerosis;
- •AIDS patients;
- •serious thrombotic or embolic events within 6 months;
- •renal insufficiency requiring hemodialysis or peritoneal dialysis;
- •pregnant or lactating women;
- •mental disorder or disease.
研究组 & 干预措施
TACE plus rAd-p53
TACE plus rAd-p53 artery injection'
干预措施: TACE plus rAd-p53 artery injection (Drug)
TACE
TACE will be applied alone
干预措施: TACE (Drug)
结局指标
主要结局
overall survival
时间窗: tumor assessment will be performed every 6 weeks from starting study treatment to death or 2 years later
overall survival
次要结局
- safety as assessed by adverse events, vital sign, lab tests, ECG and physical examination(from the first study treatment to the 30 days after the last treatment (on an average of 6 months from the start treatment))
- progression-free survival(tumor assessment will be performed every 6 weeks from starting study treatment to disease progression or 2 years later)