NCT06563869

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

Efficacy and Safety of Sintilimab in Combination With Platinum-containing Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma: a Prospective, Open, Single-arm, Single-center Clinical Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The patients selected for the study were those who were diagnosed with esophageal cancer for the first time. The recruited subjects should be: 1. Preoperatively, the main part of the tumor was located in the middle and lower part of the esophagus (below 18 cm from the incisors) as shown by gastroscopy, and the pathological type was squamous cell carcinoma as shown by biopsy. 2. Preoperatively, patients with esophageal cancer assessed by imaging (CT, MRI or PET/CT), cervical B-ultrasound and endoscopic ultrasound as potentially resectable. Potentially resectable patients were defined as those with T2-4aNxM0, stage II-IVA (AJCC staging, 8th edition, 2017) of esophageal cancer according to the 2022 Guidelines for the Diagnosis and Treatment of Esophageal Cancer of the Chinese Society of Clinical Oncology. For T2N0M0, the length of the primary tumor under endoscopic examination was required to be ≥ 2 cm, located below the neck, and ≥ 5 cm away from the cricopharyngeal muscle. 3. Signed the informed consent form and met all the inclusion and exclusion criteria of this study.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	PEG-rhG-GSF	Polyethylene glycolylated recombinant human granulocyte stimulating factor （6mg）will be given 24 hours after the end of chemotherapy.

Timeline

• Start date: 2024-02-02
• Primary completion: 2025-11-22
• Completion: 2026-11-22
• First posted: 2024-08-21
• Last updated: 2024-08-21

Locations

1 site across 1 country: China