計劃書編號219606 (AZUR 2)
NCT Number(ClinicalTrials.gov Identfier)NCT05855200
試驗執行中
2023-08-01 - 2029-01-17
Phase III
尚未開始1
召募中3
ICD-10C18.3
結腸肝(彎)曲部惡性腫瘤
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9153.0
右曲結腸惡性腫瘤
一項第3期、開放標記、隨機分配的試驗，在患有未經治療的T4N0或第三期錯配修復基因缺陷(dMMR)/高微衛星不穩定(MSI-H)的可切除結腸癌之受試者中，比較手術前後單獨使用Dostarlimab和標準照護
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試驗申請者
荷商葛蘭素史克藥廠股份有限公司台灣分公司
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試驗委託 / 贊助單位名稱
荷商葛蘭素史克藥廠股份有限公司台灣分公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 尚未開始
適應症
未經治療的T4N0或第三期錯配修復基因缺陷(dMMR)/高微衛星不穩定(MSI-H)的可切除結腸癌
試驗目的
主要目標
在患有未經治療的T4N0或第三期(可切除) dMMR/MSI-H結腸癌之受試者中，評估手術前後dostarlimab與SOC相較之下的療效
次要目標
在患有未經治療的T4N0或第三期(可切除) dMMR/MSI-H結腸癌之受試者中，評估術前輔助性dostarlimab的療效
在患有未經治療的T4N0或第三期(可切除) dMMR/MSI-H結腸癌之受試者中，估算接受手術前後dostarlimab治療與接受SOC治療的受試者在整體存活期(OS)方面的差異
在患有未經治療的T4N0或第三期(可切除) dMMR/MSI-H結腸癌之受試者中，評估手術前後dostarlimab與SOC相較之下的療效
在患有未經治療的T4N0或第三期(可切除) dMMR/MSI-H結腸癌之受試者中，評估dostarlimab與SOC相較之下的安全性及耐受性
描述dostarlimab在患有未經治療的T4N0或第三期(可切除) dMMR/MSI-H結腸癌之受試者中的藥物動力學(PK)
判定dostarlimab在患有未經治療的T4N0或第三期(可切除) dMMR/MSI-H結腸癌之受試者中的免疫原性
藥品名稱
注射液
主成份
Dostarlimab
Dostarlimab
Dostarlimab
劑型
Concentrate For Solution For Infusion
劑量
50mg/1ml
50mg/1ml
50mg/1ml
評估指標
•由盲性獨立中央審查(BICR)評估復發的無事件存活期(EFS)
其中事件的定義為：
o疾病復發，基於BICR進行的放射學評估
o疾病惡化無法手術(當地評估)
o疾病復發，基於手術後病理評估發現新病灶(當地評估)
o因任何原因死亡
o造成受試者不適合手術的治療相關毒性
其中事件的定義為：
o疾病復發，基於BICR進行的放射學評估
o疾病惡化無法手術(當地評估)
o疾病復發，基於手術後病理評估發現新病灶(當地評估)
o因任何原因死亡
o造成受試者不適合手術的治療相關毒性
主要納入條件
*患有經病理學確認而未經治療結腸腺癌。
*患有可切除的結腸腺癌，定義為臨床上T4N0或第三期。
*患有放射學上可評估的疾病。
*患有證實存在下列情況之一的腫瘤：
a.錯配修復基因缺陷(dMMR)狀態：錯配修復(MMR)狀態必須透過免疫組織化學(IHC)對MMR蛋白的表現(MLH1、MSH2、MSH6、PMS2)進行評估，其中缺失1種或多種蛋白顯示為dMMR；MMR狀態可由本地或中央參考實驗室確定；或
b.透過聚合酶連鎖反應(PCR)或組織次世代定序(NGS)確定的高微衛星不穩定(MSI-H)表型；MSI-H由本地實驗室確定。
*患有可切除的結腸腺癌，定義為臨床上T4N0或第三期。
*患有放射學上可評估的疾病。
*患有證實存在下列情況之一的腫瘤：
a.錯配修復基因缺陷(dMMR)狀態：錯配修復(MMR)狀態必須透過免疫組織化學(IHC)對MMR蛋白的表現(MLH1、MSH2、MSH6、PMS2)進行評估，其中缺失1種或多種蛋白顯示為dMMR；MMR狀態可由本地或中央參考實驗室確定；或
b.透過聚合酶連鎖反應(PCR)或組織次世代定序(NGS)確定的高微衛星不穩定(MSI-H)表型；MSI-H由本地實驗室確定。
主要排除條件
Exclusion Criteria:
Has distant metastatic disease.
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery
Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollment
Has any history of interstitial lung disease or pneumonitis
Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice
Has a history of allogenic stem cell transplantation or organ transplantation
Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention
Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of FOLFOX or CAPEOX
Has distant metastatic disease.
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery
Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollment
Has any history of interstitial lung disease or pneumonitis
Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice
Has a history of allogenic stem cell transplantation or organ transplantation
Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention
Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of FOLFOX or CAPEOX
試驗計畫預計收納受試者人數
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台灣人數
12 人
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全球人數
711 人
