NCT05022654

SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.

Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 Combined With Irinotecan in the Treatment of Recurrent and Metastatic Esophageal Squamous Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, open label Phase II clinical study is performed in patients with relapsed and metastatic esophageal squamous cell carcinoma progressed on prior PD-1/L1 antibody with or without chemotherapy. This study is investigating the safety and efficacy of SI-B001 at optimal combination dose with irinotecan in patients.

Conditions

• Esophageal Squamous Cell Carcinomas

Interventions

Type	Name	Description
DRUG	SI-B001	Administered by intravenous drip every 2 weeks (Q2W). The first intravenous infusion is 120 min±10min. If the infusion reaction can be tolerated during the first infusion, the subsequent infusion can be completed in 60-120 min.
DRUG	Irinotecan	The dose of irinotecan was 180mg/m2 Q2W, the infusion method was according to the drug instructions, SI-B001 and irinotecan were used on the same day, and irinotecan was injected after SI-B001 infusion.

Timeline

• Start date: 2021-12-13
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-08-26
• Last updated: 2025-09-26

Locations

6 sites across 1 country: China