NCT03398122Unknown不适用
Study of Apatinib Combined With TACE in Advance Hepatocellular Carcinoma
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2017年11月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
the purpose of this study is to evaluate the efficacy and safety of aptinib in patients with advanced HCC
详细描述
HCC The is a common malignancy in the world, especially in China. Advanced HCC treatment is difficult and the prognosis is poor, which is still a great challenge and threat to the medical profession. The advent of the molecular targeted drug, Sola, has made the treatment dilemma of advanced HCC a breakthrough, but the efficacy and economic health ratio is far from satisfactory. After Sola, many new molecular targeted drugs were studied, but failed.
Although multiple treatment options, but for HCC Patient-recommended treatment programs require systematic treatment and surgery, TACE , local ablation and radiotherapy and other multidisciplinary means of combination, the selection of appropriate patients, appropriate means and timing to achieve individualized treatment.
- Aptinib Union TACE can be generated through embolization and angiogenesis by the dual target of vascular suppression;2. TACE induces hypoxia, leading to an increase in the number of hypoxia-inducing factors that increases VEGF and PDGFR , while VEGF the and PDGFR may be important factors that induce tumor recurrence by stimulating tumor angiogenesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Age: 18-70 years old;
- •initial treatment diagnosed by histopathological or cytological examination BCLC Staging B/C Hepatocellular carcinoma of the liver ( HCC ) and at least one of the largest tumors in measurable lesions ≤15cm ;
- •Child-pugh liver function Rating: A level, B level;
- •BCLC Staging as B / C period;
- •before join in the group 1 weeks ECOG PS Rating: 0-1 score; estimated Lifetime ≥12 Week; Lab metrics meet the following criteria: ( 1 ) Blood routine check:
- •ANC≥1.5x109/L;
- •PLT≥60x109/L; ( 2 ) Biochemical Examination:
- •ALB≥29 g/L;
- •ALT and AST<2.5*ULN;
- •TBIL ≤ 2*ULN;
- •Cr ≤ 1.5*ULN;
- •women of childbearing age must be pregnancy tests before join in the group in 7 days;
- •Participants volunteered to join this study should sign informed consent, with good compliance and follow-up.
排除标准
- •Central hepatic artery / hepatic venous fistula in patients with hepatocellular carcinoma, diffuse liver cancer patients, with large vascular invasion of liver cancer patients (including portal vein tumor thrombus);
- •hepatobiliary cell carcinoma and mixed cell carcinoma are known; previous ( 5 year) or at the same time suffering from other incurable malignancies, except for the cured basal cell carcinoma of the skin and cervical carcinoma in situ;
- •clinically symptomatic ascites that requires therapeutic celiac puncture or drainage with high blood pressure and cannot be reduced to normal range by anti hypertensive medications (systolic pressure > 140 mmHg , diastolic pressure >90 mmHg );
- •Suffering Ⅱ above-level myocardial ischemia or myocardial infarction, control of poor arrhythmia (including QTC inter-phase male ≥450 ms , female ≥470 ms );
- •Follow NYHA Standard Ⅲ ~ Ⅳ grade heart insufficiency or heart color Doppler ultrasonography: LVEF (left ventricular ejection fraction) < 50% ;
- •There are various factors affecting oral medication (e.g.inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption);
- •previous within 6 months there is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding, such as: bleeding risk of esophageal varices, local active ulcer lesions, fecal occult blood ≥ ( ++ ) not in group; fecal occult blood (+ ), requiring gastroscopy;
- •before participating in this study There were abdominal fistula, gastrointestinal perforation or celiac abscess in the day;
- •Coagulation dysfunction ( INR > 1.5 or prothrombin time ( PT ) > ULN+4 seconds), with bleeding tendencies or undergoing thrombolysis or anticoagulant therapy;
- •patients who have undergone central nervous system metastasis or known brain metastases;
- •patients with objective evidence of the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung impairment;
- •urine proteins are routinely shown ≥++ or confirmed 24 hour urine protein ration > 1.0 g ;
- •before participating in the study 7 days use strong-effect in CYP3A4 inhibitor therapy, or prior to participating in the study 12 days use the strong-effect in CYP3A4 inducer Therapy;
- •pregnant or lactating women who are not willing or unable to take effective contraceptive measures;
- •A history of mental illness, or psychotropic substance abuse;
- •Union HIV infected patients;
研究组 & 干预措施
Apatinib combined with TACE
Experimental
patients received Aptinib, 250 mg daily after TACE treatment, for 4-6 weeks
干预措施: TACE (Procedure)
Apatinib combined with TACE
Experimental
patients received Aptinib, 250 mg daily after TACE treatment, for 4-6 weeks
干预措施: Apatinib (Drug)
chemoemtranscatherer arterial bolization
Placebo Comparator
epirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles.
干预措施: Apatinib (Drug)
结局指标
主要结局
PFS
时间窗: one and a half year
progression free survival
次要结局
- TTP(one and a half year)
- DCR(one and a half year)
- ORR(one and a half year)
- OS(one and a half year)
- QOL(one and a half year)
研究者
研究点 (1)
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