SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Study ID
- NCT05022654
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Esophageal Squamous Cell Carcinomas
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- SI-B001 — DRUGAdministered 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.
- Irinotecan — DRUGThe 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.
Study Details
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.
Key Dates
- Start date
- Dec 13, 2021
- Status verified
- Sep 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 22 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: SI-B001 combined with irinotecanPatients with recurrent metastatic esophageal squamous cell carcinoma who had failed first-line therapy with PD-1(L1) monoclonal antibody plus platinum-based chemotherapy were enrolled.
Primary Outcome Measure
ORR [ Time Frame: Up to approximately 24 months ]