Clinical Trials List
2025-09-18 - 2028-09-28
Phase II
Recruiting4
ICD-10C15.8
Malignant neoplasm of overlapping sites of esophagus
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9150.8
Malignant neoplasm of other specified part of esophagus
A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/07/06
Investigators and Locations
Co-Principal Investigator
- Li-Tzong Chen 無
- Jeng-Shiun Du 無
- Wang Yao-Kuang 無
- Yi-Hsun Chen 無
- Tsung-Jang Yeh 無
- 王閔宏 無
- 洪國禎 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chien-An Liu
- 方文良
- Yi-Ping Hung
- 徐博奎 Division of Hematology & Oncology
- 林泰祺
- 黃國宏 Division of Hematology & Oncology
- 姜乃榕
- Tien-Hua Chen Division of Hematology & Oncology
- 郭懿萱 Division of Hematology & Oncology
- 邱乃祈
- 宮慶雲 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jen-Shi Chen
- Wen-Chi Shen
- Hung-Chih Hsu
- Ming-Mo Hou
- Wen-Chi Chou
- Po-Jung Su Division of General Surgery
- 徐潤德
- Tai-Sen Yeh
- 李兆偉
- 蔡悅如 Division of Ophthalmology
- 陳建銘
- 劉耿豪 Division of General Surgery
- 蔡駿逸 Division of General Surgery
- Shih-Chiang Huang
- 湯文誠
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 趙盈瑞 Division of General Surgery
- Chien-Jui Huang Division of General Surgery
- Chih-Chieh Yen Division of General Surgery
- Chia-Jui Yen Division of General Surgery
- 廖亭凱 Division of General Surgery
- 蘇炳睿 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Injection
Frozen Crystal Injection
Active Ingredient
Rilvegostomig
DS-8201a
Dosage Form
270
243
Dosage
750 mg
100mg
Endpoints
Inclution 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
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
The Estimated Number of Participants
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Taiwan
10 participants
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Global
150 participants
