NCT06078657

IBI110 Combined With Sintilimab in Second-line Advanced or Metastatic Esophageal Squamous Cell Carcinoma(ESCC)

Prospective, Single-arm Phase II Exploratory Study of the Efficacy and Safety of IBI110 Combined With Sintilimab in Advanced or Metastatic Esophageal Squamous Cell Carcinoma That Has Failed First-line Anti-PD-1 Antibody Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, prospective, single-arm Phase II clinical study to evaluate the efficacy and safety of IBI110 in combination with Sintilimab in subjects with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed first-line treatment with PD-1 inhibitors combined with chemotherapy. Patients who meet the inclusion criteria will be treated with IBI110 combined with Sintilimab until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of therapy for other reasons specified in the protocol. RECIST v1.1 was used for clinical tumor imaging evaluation every 6 weeks during treatment.

Conditions

• Esophageal Squamous Cell Carcinoma (ESCC)
• PD-1 Inhibitors

Interventions

Type	Name	Description
DRUG	IBI110+Sintilimab	IBI110, 200mg, intravenously on the first day of each cycle, every 3 weeks for 1 cycle (Q3W), and the maximum use time was 2 years. Sintilimab, 200mg, intravenously on the first day of each cycle, every 3 weeks as a cycle (Q3W), and the maximum use time was 2 years.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2023-10-12
• Last updated: 2023-10-12

Locations

1 site across 1 country: China