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Sintilimab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Locally Advanced Gastroesophageal Junction Cancer
Sponsor: Anhui Medical University
Summary
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.
Official title: A Multicenter Prospective Clinical Study of Sintilimab Combined With Chemoradiotherapy as Neoadjuvant Treatment for Locally Advanced Gastroesophageal Junction Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-10-01
Completion Date
2028-10-01
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Sintilimab
Oxaliplatin 130 mg/m² administered by intravenous infusion on Day 1 of a 21-day cycle during induction and optional consolidation XELOX treatment.
Capecitabine
During induction and optional consolidation XELOX treatment, capecitabine is administered at 1000 mg/m² orally twice daily on Days 1-14 of each 21-day cycle. During concurrent chemoradiotherapy, capecitabine is administered at 825 mg/m² orally twice daily on radiotherapy days as a radiosensitizer.
Oxaliplatin
Oxaliplatin 130 mg/m² administered by intravenous infusion on Day 1 of a 21-day cycle during induction and optional consolidation XELOX treatment.
Radiation
Intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) to the primary tumor and regional lymphatic drainage areas, with a total dose of 45 Gy in 25 fractions, administered 5 days per week for 5 weeks.
Locations (1)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China