計劃書編號D9804C00001
NCT Number(ClinicalTrials.gov Identfier)NCT07069712
試驗執行中
2025-09-18 - 2028-09-28
Phase II
召募中4
ICD-10C15.8
食道重疊部位之惡性腫瘤
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9150.8
食道其他特定部位之惡性腫瘤
一項開放性、多藥物、多中心、第II 期平台試驗之主計畫，評估新型藥物或併用治療作為手術前後治療用於局部晚期可切除胃食道腺癌參與者的安全性、耐受性、藥物動力學與初步抗腫瘤活性 (GEMINI-PeriOp GC)
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試驗申請者
百瑞精鼎國際股份有限公司
-
試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
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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 召募中
適應症
Gastroesophageal Adenocarcinoma-
試驗目的
-NA
藥品名稱
N/A
N/A
N/A
N/A
N/A
主成份
AZD0901
Rilvegostomig
T-DXd (DS-8201a)
Rilvegostomig
T-DXd (DS-8201a)
劑型
N/A
N/A
N/A
N/A
N/A
劑量
-
評估指標
-NA
主要納入條件
Inclusion Criteria:
Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
Participants who are CLDN18.2-positive and HER2-negative in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ and bone marrow function
Body weight > 35 kg
Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
Participants who are CLDN18.2-positive and HER2-negative in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ and bone marrow function
Body weight > 35 kg
主要排除條件
Exclusion Criteria:
Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer.
Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment
Central nervous system (CNS) pathology
Uncontrolled infections
Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis
History of another primary malignancy
Participants with any known or suspicious distant metastasis
Uncontrolled hepatitis B and/or chronic or active hepatitis B
Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention
Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer.
Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment
Central nervous system (CNS) pathology
Uncontrolled infections
Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis
History of another primary malignancy
Participants with any known or suspicious distant metastasis
Uncontrolled hepatitis B and/or chronic or active hepatitis B
Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention
試驗計畫預計收納受試者人數
-
台灣人數
10 人
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全球人數
150 人
