計劃書編號A6181054
試驗已結束
2006-01-01 - 2007-12-01
Phase II
終止收納2
ICD-10C16.0
賁門部惡性腫瘤
ICD-10C7A.092
胃惡性類癌
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9151.0
胃賁門部惡性腫瘤
以SU011248治療曾經接受過化學治療後，疾病復發或惡化之轉移或晚期胃癌病人，評估其有效性與安全性之第二期之開放性、全球多中心臨床試驗
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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
多國多中心
-
更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 終止收納
適應症
復發或轉移性胃癌
試驗目的
以SU011248治療曾經接受過化學治療後，疾病復發或惡化之轉移或晚期胃癌病人，評估其有效性與安全性之第二期之開放性、全球多中心臨床試驗。
藥品名稱
膠囊劑
主成份
Sunitinib malate
劑型
130
劑量
50 mg
評估指標
- Best Overall Response
- Objective Response (Complete Response (CR) or Partial Response (PR))
- Objective Response (Complete Response (CR) or Partial Response (PR))
主要納入條件
Inclusion Criteria:
Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented
Disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion
Evidence of measurable disease by radiographic technique
Adequate organ function.
Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented
Disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion
Evidence of measurable disease by radiographic technique
Adequate organ function.
主要排除條件
Exclusion Criteria:
Clinically relevant ascites (i.e. requiring paracentesis)
Severe weight loss
NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment
Diagnosis of second malignancy within last 3 years
History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
Known HIV
Serious acute or chronic illness
Current treatment on another clinical trial
Pregnant or breastfeeding
Clinically relevant ascites (i.e. requiring paracentesis)
Severe weight loss
NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment
Diagnosis of second malignancy within last 3 years
History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
Known HIV
Serious acute or chronic illness
Current treatment on another clinical trial
Pregnant or breastfeeding
試驗計畫預計收納受試者人數
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台灣人數
10 人
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全球人數
160 人
