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

A Multicenter Prospective Clinical Study of Sintilimab Combined With Chemoradiotherapy as Neoadjuvant Treatment for Locally Advanced Gastroesophageal Junction Tumors

Sponsor
Anhui Medical University (Academic or other)
Enrolment
50 planned
Conditions
Gastroesophageal Junction Adenocarcinoma
Interventions
Sintilimab; Capecitabine; Oxaliplatin; Radiation
Ages
adults, older adults
Registry
NCT07859410

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Pathological Complete Response Rate

History

  1. Primary completion expected

  2. Registered

  3. Started