NCT06718205

Nimotuzumab Combined With Sintilimab and Chemotherapy for Advanced Esophageal Squamous Cell Carcinoma

Open-label, Single-arm, Multicenter Phase II Study of Nimotuzumab Injection Combined With Sintilimab and Chemotherapy as First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, multicenter study. The patients were given chemotherapy with nimotuzumab and sindilimab. To analyze the efficacy and safety of nimotuzumab combined with sindilizumab and chemotherapy in first-line treatment of advanced or recurrent or metastatic esophageal cancer.

Detailed description

This study is a prospective, single-arm, multicenter study. Patients with locally advanced, metastatic esophageal squamous cell carcinoma who had received previous (new adjuvant) / radical treatment (including radical surgical resection and radical chemoradiotherapy) who had relapsed more than 6 months and did not receive other antitumor treatment The patients were given 4-6 cycles of chemotherapy with nimotuzumab and sindilimab and TP (according to the degree of tolerance), and continued maintenance therapy with nimotuzumab and sindilimab. Medication continued until disease progression or the patient was intolerable or the patient died or withdrawal from the study, nimotuzumab and sindilimab for 2 years and follow-up observation for 1 year. To analyze the efficacy and safety of nytuzumab combined with cindilizumab and chemotherapy in first-line treatment of advanced or recurrent or metastatic esophageal cancer.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Nimotuzumab	Combined chemotherapy phase Nimotuzumab 400mg，I.V.，D1，QW Maintenance treatment period:Until unbearable or PD Nimotuzumab 400mg，I.V.，D1，Q3W
DRUG	Sintilimab	Sintilimab 200mg，I.V.，D1，Q3W，Until unbearable or PD
DRUG	Paclitaxel-albumin	Paclitaxel-albumin 200 mg/m2，I.V.，D1，Q3W，4-6 Cycle
DRUG	Cisplatin	Cisplatin:75 mg/m2，I.V.，D1,Q3W，4-6 Cycle

Timeline

• Start date: 2023-03-08
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-12-05
• Last updated: 2024-12-05

Locations

1 site across 1 country: China