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
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 王閔宏 無
- Wang Yao-Kuang 無
- Yi-Hsun Chen 無
- 洪國禎 無
- Tsung-Jang Yeh 無
- Li-Tzong Chen 無
- Jeng-Shiun Du 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林泰祺 Division of Hematology & Oncology
- Yi-Ping Hung Division of Hematology & Oncology
- 郭懿萱 Division of Hematology & Oncology
- 方文良 Division of Hematology & Oncology
- Chien-An Liu Division of Hematology & Oncology
- 徐博奎 Division of Hematology & Oncology
- 黃國宏 Division of Hematology & Oncology
- 邱乃祈 Division of Hematology & Oncology
- 唐振育 Division of Hematology & Oncology
- Tien-Hua Chen Division of Hematology & Oncology
- 姜乃榕 Division of Hematology & Oncology
- 宮慶雲 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李兆偉 Division of General Surgery
- 徐潤德 Division of General Surgery
- 陳建銘 Division of General Surgery
- Tai-Sen Yeh Division of General Surgery
- 蔡駿逸 Division of General Surgery
- Ming-Mo Hou Division of General Surgery
- Jen-Shi Chen Division of General Surgery
- 黃文冠 Division of General Surgery
- 蔡悅如 Division of Ophthalmology
- Wen-Chi Shen Division of General Surgery
- Hung-Chih Hsu Division of General Surgery
- 湯文誠 Division of General Surgery
- Po-Jung Su Division of General Surgery
- Wen-Chi Chou Division of General Surgery
- Yung-Chia Kao Division of General Surgery
- Shih-Chiang Huang Division of General Surgery
- 劉耿豪 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Rilvegostomig
DS-8201a
Dosage Form
Dosage
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
