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Sintilimab With Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

StatusRecruiting
PhasePhase 3
Started2024-02-02
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 21, 2024 (before its estimated November 22, 2025 completion). Its status may not reflect the trial's current state.
This study is a prospective, open-label, single-arm, single-center clinical study, aiming to evaluate the efficacy and safety of sintilimab combined with platinum-based chemotherapy + pegylated recombinant human granulocyte stimulating factor as neoadjuvant treatment for resectable esophageal squamous cell carcinoma patients. In the study, all patients who meet the inclusion criteria will receive sintilimab combined with platinum-based chemotherapy for 2 cycles (21 days as one cycle) as neoadjuvant treatment according to the study plan. Pegylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy, and radical surgical treatment will be received within 3-6 weeks after the completion of the last neoadjuvant treatment. Whether the subjects need adjuvant treatment after surgery and the adjuvant treatment plan will be determined by the investigators. All subjects need to complete the follow-up plan formulated by the study after surgery.
Trial Details
NCT Number NCT06563869
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Esophageal Squamous Cell Carcinoma
Enrollment 40 participants
Start Date 2024-02-02
Primary Completion 2025-11-22 (estimated)
Study Completion 2026-11-22 (estimated)
Updated on ClinicalTrials.gov 2024-08-21