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)
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Aged18-75 years, gender is not limited;
• Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
• HER2-Positive (IHC3+or IHC2+/FISH+) ;
• Has at least 1 measurable lesion as determined by RECIST 1.1;
• There is no systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Adequate organ function;
• The life expectancy is at least 3 months;
Locations
Other Locations
China
Binzhou Medical University Hospital
NOT_YET_RECRUITING
Binzhou
Shengli Oilfield Central Hospital
RECRUITING
Dongying
Jinan Third People's Hospital
RECRUITING
Jinan
Shandong Provincial Hospital Affiliated to Shandong First Medical University
RECRUITING
Jinan
Shandong Provincial Third Hospital
RECRUITING
Jinan
Shandong Univerisity Qilu Hospital
RECRUITING
Jinan
Affiliated Hospital of Jining Medical College
RECRUITING
Jining
Liaocheng People's Hospital
RECRUITING
Liaocheng
Linyi Cancer Hospital
RECRUITING
Linyi
Qilu Hospital of Shandong University(Qingdao)
RECRUITING
Qingdao
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Taian City Central Hospital
NOT_YET_RECRUITING
Taian
The Second Affiliated Hospital of Shandong First Medical University
RECRUITING
Taian
Tengzhou Central People's Hospital
RECRUITING
Tengzhou
Weifang Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Weifang
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Yantaishan Hospital
RECRUITING
Yantai
The First Affiliated Hospital of Zhengzhou University