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Sintilimab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Locally Advanced Gastroesophageal Junction Cancer

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This is a multicenter, prospective, single-arm, open-label exploratory clinical study evaluating sintilimab combined with neoadjuvant chemotherapy, concurrent chemoradiotherapy, and optional consolidation chemotherapy in patients with locally advanced gastroesophageal junction adenocarcinoma. Eligible participants will receive one cycle of sintilimab plus XELOX induction therapy, followed by sintilimab plus capecitabine concurrent radiotherapy. Optional consolidation with sintilimab plus XELOX may be administered according to treatment response, toxicity recovery, nutritional status, surgical feasibility, and multidisciplinary team assessment. Patients who are considered suitable for surgery will undergo radical resection and regional lymph node dissection. The primary endpoint is pathological complete response rate.
Trial Details
NCT Number NCT07859410
Lead Sponsor Anhui Medical University
Collaborators: The Second Hospital of Anhui Medical University, Suzhou Municipal Hospital, First Affiliated Hospital of Wannan Medical College, Fuyang people's hospital
Conditions
(from sponsor)
Gastroesophageal Junction Adenocarcinoma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov