計劃書編號1132070011-12
2008-05-01 - 2010-12-31
Phase II
終止收納1
ICD-10C22.0
肝細胞癌
ICD-10C22.2
肝芽細胞瘤
ICD-10C22.3
肝血管肉瘤
ICD-10C22.4
肝其他肉瘤
ICD-10C22.7
其他特定肝上皮細胞癌
ICD-10C22.8
原發性肝惡性腫瘤，未明示型
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9155.0
原發性肝惡性腫瘤
口服 Thalidomide及Tegafur/uracil 預防高危險性肝細胞癌復發之第二期臨床試驗。
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試驗委託 / 贊助單位名稱
N/A
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臨床試驗規模
台灣單中心
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更新日期
2025/08/20
試驗主持人及試驗醫院
實際收案人數
0 終止收納
適應症
試驗目的
為瞭解thalidomide及tegafur/uracil 之使用，是否真正能夠預防肝癌之復發，故進行第二期臨床試驗。擬收錄之患者為腫瘤分期為第一至第三期，已接受過手術治療，符合高危險復發因子，如腫瘤大於5公分、肝門靜脈受侵犯、淋巴結受侵犯、有多個腫瘤、沒有完整的肝腫瘤囊形等。
藥品名稱
Thalidomide及Tegafur/uracil
主成份
tegafur/uracil
thalidomide
thalidomide
劑型
capsules
劑量
100
50
50
評估指標
1.主要評估指標：
1-year recurrence-free survival rate
2.次要評估指標：
recurrence-free survival
safety profile
1-year recurrence-free survival rate
2.次要評估指標：
recurrence-free survival
safety profile
主要納入條件
1. 主要納入條件：
a. stage I-III（TNM: T1-T3） hepatocellular carcinoma
b. previously received curative surgery
c. presence at least one and no more than three of the following risk factors ,
i. Tumor size ≧ 5 cm
ii. presence of microscopic or macrovascular venous invasion
iii. presence of satellite nodules/addition nodules
iv. no capsular formation
v. multiple tumors
d. performance status of ECOG 0, 1
e. age between 20 and 75 years
f. no residual or recurrent tumors detected by computed tomography (CT) within 3-4 weeks after surgery
g. written informed consent to participate in the trial
2. 主要排除條件：
a. other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ prior to the entry of study
b. previously received chemotherapy
c. less than 2 weeks since previous radiotherapy/surgery
d. white blood cell (WBC) less than 3,000/mm3 and absolute neutrophil count (ANC) less than 1,500/mm3, and platelets less than 100,000/mm3
e. serum bilirubin greater than 1.5 times the upper limit of normal range (ULN)
f. alanine aminotransferase (ALT) or aspartate transaminase (AST) greater than 5 times the ULN
a. stage I-III（TNM: T1-T3） hepatocellular carcinoma
b. previously received curative surgery
c. presence at least one and no more than three of the following risk factors ,
i. Tumor size ≧ 5 cm
ii. presence of microscopic or macrovascular venous invasion
iii. presence of satellite nodules/addition nodules
iv. no capsular formation
v. multiple tumors
d. performance status of ECOG 0, 1
e. age between 20 and 75 years
f. no residual or recurrent tumors detected by computed tomography (CT) within 3-4 weeks after surgery
g. written informed consent to participate in the trial
2. 主要排除條件：
a. other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ prior to the entry of study
b. previously received chemotherapy
c. less than 2 weeks since previous radiotherapy/surgery
d. white blood cell (WBC) less than 3,000/mm3 and absolute neutrophil count (ANC) less than 1,500/mm3, and platelets less than 100,000/mm3
e. serum bilirubin greater than 1.5 times the upper limit of normal range (ULN)
f. alanine aminotransferase (ALT) or aspartate transaminase (AST) greater than 5 times the ULN
試驗計畫預計收納受試者人數
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台灣人數
40 人
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全球人數
0 人
