Sintilimab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Locally Advanced Gastroesophageal Junction Cancer
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.
Timeline
- Start
- 2026-10-01
- Primary completion
- 2028-10-01
- Completion
- 2028-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 825 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |