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Brief Title: Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction
Official Title: Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction: a Single-arm,Open-label,Phase II Clinical Study
Study ID: NCT05918419
Brief Summary: Investigators conduct the clinical trial to further explore the efficacy and safety of Neoadjuvant chemoradiation Plus Serpluimab in Patients with locally advanced Adenocarcinoma of Gastroesophageal Junction
Detailed Description: 1. Target population: patients with locally advanced adenocarcinoma of Gastroesophageal Junction (cT3-4aN+M0). 2. Primary objective: pathological complete remission (pCR) rate of neoadjuvant chemoradiation plus Serpluimab in patients with locally advanced Adenocarcinoma of Gastroesophageal Junction 3. Patients will be given the perioperative treatment as below once recruited: induction chemotherapy :Serplulimab 300mg iv.gtt d1+Oxaliplatin130mg/m2 iv.gtt d1,+S1 40mg/m2 p.o.b.i.d. d1\~d14(up to 60mg) .Every three weeks for one cycle. After the induction chemotherapy,concurrent chemoradiation will be strated:Serplulimab 300mg iv.gtt d1,+Oxaliplatin100mg/m2 iv.gtt d1+S1 40mg/m2 p.o.b.i.d. d1\~d14(up to 60mg), every three weeks , the total of two cycles . Radiation total dose: 45Gy/25F, 1.8Gy/d. Resectable patients will receive D2 resection After 6-8weeks Neoajuvant therapy 4. Number of subjects: 35 patients. Number of centers: 1 site(Peking Union Medical College Hospital)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Peking Union Medical College Hospital, Beijing, , China