NCT03338647Unknown3 期
Randomized Study of Stereotactic Body Radiation Therapy (SBRT) Versus Transarterial Chemoembolization (TACE) in Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Progression (total of local, intra- and extrahepatic)
研究概览
简要总结
Randomized study of stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) in locally advanced hepatocellular carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC (biopsy or radiological diagnostic (>1 cm, enhancing in arterial phase and wash-out in later phases).
- •Number of lesions: not more than 3 lesions
- •Lesion size: up to 10 cm for a single lesion (and up to 10 cm cumulative diameter, if there is more than 1 lesion)
- •Child-Pugh A or B (<7) on examination within 6 weeks prior to study entry
- •BCLC Stage A/B
- •Must be fit (eligible) for SBRT and TACE
- •Unsuitable/unwilling for resection or transplant or radiofrequency ablation (RFA) or if these options are not available
- •Distance between GTV (lesion) and luminal structures (including esophagus, stomach, duodenum, small or large bowel) is >10 mm
- •All blood work obtained within 2 weeks prior to study entry with adequate organ function defined as follows:
- •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- •Platelets ≥50,000 cells/mm3
- •Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
- •Total bilirubin < 2 mg/dL
- •Prothrombin time/INR < 1.4 (unless on Coumadin/Warfarin)
- •Albumin ≥ 28 g/L
- •AST (and ALT) < 5 times ULN
- •Serum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min
- •Left-ventricular ejection fraction >50% (cardiac ejection fraction should be measured in case of history of cardio-vascular disease.
- •May have had previous surgery, ethanol injection and RFA to the liver
排除标准
- •• Not suitable for clinical trial or follow-up
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (Note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible). No active cancer therapy.
- •Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE)
- •Non-enhancing HCC on CT or CT-angio or
- •Portal vein thrombosis/macroscopic venous invasion
- •Arterio-portal and arterio-venous fistulas observed on pre-study imaging (if it is found during the TACE, the fistula may be embolized before injection of the drug).
- •Evidence of metastatic disease including nodal or distant metastases.
- •Previous TACE or radiation to the liver (including SIRT)
- •Life-threatening condition (including untreated HIV and active hepatitis B/C)
- •Detectable HBeAg and HBV viral load > 20,000 IU/mL or
- •HBeAg-negative chronic hepatitis B and HBV viral load >2,000 IU/mL
- •If HBV-DNA copy is higher than 500 copies/ml, anti-viral therapy, such as Entecavir followed by observation for 2 weeks.
- •If anti-HCV antibody is positive (may be false positive) and increased HCV viral load indicating active disease. Active HCV should be treated sufficiently before inclusion in the study. Below 2 million copies per milliliter (mL) is related to chronic hepatitis C that does not need antiviral therapy.
- •Patients with active hepatitis B or C should be on treatment for at least 4 weeks before inclusion in the trial
- •On sorafenib or other antineoplastic drug therapy within 7 days before inclusion (not accepted until time of progression).
- •Pregnancy or women of childbearing potential require a negative pregnancy test within 28 days
研究组 & 干预措施
TACE
Active Comparator
Transarterial chemoembolization with drug eluted beads or doxorubicin/lipiodol
干预措施: DEB (Drug)
SBRT
Experimental
Stereotactic radiation therapy with risk adapted dose prescription
干预措施: SBRT (Radiation)
结局指标
主要结局
Progression (total of local, intra- and extrahepatic)
时间窗: 1 year
Modified RECIST
次要结局
- Response(3 months)
- Local control of treated tumor(1 year)
- Overall survival(1 year)
- Intrahepatic failure(1 year)
- Extrahepatic failure(1 year)
- Treatment related toxicity(1 year)
- Cost-benefit(1 year)
研究者
研究点 (1)
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Unknown
不适用
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终止
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终止
不适用
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