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First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)
Sponsor: Qilu Hospital of Shandong University
Summary
This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.
Official title: A Phase II, Open-Label, Multicenter Trial Comparing Disitamab Vedotin Plus Sintilimab and S-1 With Trastuzumab Plus Chemotherapy ± Sintilimab for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (RCTS2)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2024-10-17
Completion Date
2027-12-31
Last Updated
2024-12-31
Healthy Volunteers
No
Interventions
Disitamab Vedotin
2.5 mg/kg IV every 3 weeks
Sintilimab
200 mg IV every 3 weeks
S-1
40-60 mg BID for 14 days, every 3 weeks
Trastuzumab
First load dose is 8.0mg/kg , then 6.0 mg/kg IV every 3 weeks
Oxaliplatin
130 mg/m2 Q3W
Capecitabine
1000 mg/m² Q3W
5-FU
800 mg/m²
Cisplatin
80 mg/m²
Locations (20)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Shengli Oilfield Central Hospital
Dongying, Shandong, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Shandong Provincial Third Hospital
Jinan, Shandong, China
Shandong Univerisity Qilu Hospital
Jinan, Shandong, China
Jinan Third People's Hospital
Jinan, Shandong, China
Affiliated Hospital of Jining Medical College
Jining, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Qilu Hospital of Shandong University(Qingdao)
Qingdao, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Taian City Central Hospital
Taian, Shandong, China
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China
Tengzhou Central People's Hospital
Tengzhou, Shandong, China
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Yantaishan Hospital
Yantai, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
Zibo First People's Hospital
Zibo, Shandong, China