KCT0002755进行中（未招募）未知
A study to evaluate efficacy and safety of TheraSphere and resection combination therapy in patients with single large (> 5cm, long diameter) hepatocellular carcinoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1) Signed written informed consent
- •2) Clinical or histological diagnosis of HCC based on the guidelines of the American Association for the Study of Liver Diseases (AASLD).
- •3) Single large (> 5cm, long diameter) lesion that is typically enhanced* and bi-dimensionally measurable by multiphasic spiral CT scan and dynamic contrast-enhanced MRI.
- •4) Tumor conditions confirmed by abdominal imaging (contrast enhanced CT ± MRI) performed within 28 days prior to the enrollment: Stage A HCC according to the Barcelona Clinic of Liver Cancer (BCLC)
- •5) Age of at least 19 years and less than 80 years.
- •6) ECOG Performance Status of 0.
- •7) Child-Pugh class A (Child-Pugh score =6).
- •8) Life expectancy of at least 16 weeks.
- •9) Patients with bile duct involvement can be enrolled if patients have adequate bone marrow, liver, and renal function
- •10) Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements (no transfusion, no restoration), conducted screening: Data can be used within 14 days of screening.
- •- Hemoglobin = 8.0g/dL
- •- Absolute neutrophil count (ANC) = 1,000/mm3
- •- Platelet count = 100,000/µL
- •- Total bilirubin = 1.2mg/dL
- •- Serum albumin = 3.5g/dL
- •- ALT and AST < 5 × upper limit of normal
- •- PT-INR = 1.7
排除标准
- •1) Diffuse infiltrative tumor type
- •2) Presence of separate daughter nodule
- •3) Poorly defined and/or mixed-irregular tumor margin
- •4) Definitive combined HCC-cholangiocarcinoma on images
- •5) A history of receiving any systemic therapy of the molecularly targeted agents, immunotherapy, external beam radiation to the liver or cytotoxic chemotherapy for the treatment of HCC
- •6) Presence of extrahepatic HCC: Involvement of vessels [major branch of hepatic vein invasion; major branch of portal vein invasion from the third or first order portal vein branchlower order branch (Vp1Vp3) to main portal vein (Vp4)]; lymph node, metastasis
- •7) History or presence of hepatic encephalopathy
- •8) Ascites, moderate, large or intractable
- •9) Active clinically serious infections (> grade 2, NCI-CTCAE version 4.02), including spontaneous bacterial peritonitis.
- •10) Untreated active chronic hepatitis B
- •11) Esophageal or gastric varices = F2 (grade 2) with red color sign positive without prophylaxis (non-selective beta-blocker or endoscopic variceal ligation) or history of variceal bleeding without endoscopic variceal ligation/ injection sclerosis
- •12) Active ulcer of stomach or duodenum: untreated or presence of visible vessel
- •13) Any major surgery within 4 weeks, or any minor surgery within 2 weeks prior to signing the informed consent form
- •14) Candidate for liver transplantation and/or a history of liver transplantation
- •15) History of cardiac diseases: congestive heart failure greater than NYHA class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension and diabetes mellitus
- •16) History of AIDS/HIV infection
- •17) Seizure disorder requiring medication (such as steroids or anti-epileptics)
- •18) History of organ allograft
- •19) Evidence or history of bleeding diathesis, or thromboembolic events requiring treatment
- •20) Current renal dialysis
- •21) Previous or concurrent cancer that has a primary site or histology distinct from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis, and T1] or any cancer curatively treated less than 3 years prior to enrollment.
- •22) History of alcohol abuse (male > 210 g/week, female 140 g/week)
- •23) Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques.
- •24) Shunting of blood to the lungs that could result in delivery of greater than 16.5 mCi of yttrium-90 to the lungs. Radiation pneumonitis has been seen in patients receiving doses to the lungs greater than 30 Gy in a single treatment.
- •25) Hepatic artery catheterization is contraindicated; such as patients with vascular abnormalities or bleeding diathesis.
- •26) Severe liver dysfunction or pulmonary insufficiency
- •27) Pregnant or breast feeding women, or impossible to use of reliable methods of contraception
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