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NOT YET RECRUITING
NCT07859410
NA

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

Sponsor: Anhui Medical University

View on ClinicalTrials.gov

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

Interventions

DRUG

Sintilimab

Oxaliplatin 130 mg/m² administered by intravenous infusion on Day 1 of a 21-day cycle during induction and optional consolidation XELOX treatment.

DRUG

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.

DRUG

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

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