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Spots Global Cancer Trial Database for Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction

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Trial Identification

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

Interventions

Serplulimab

Study Description

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)

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Peking Union Medical College Hospital, Beijing, , China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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