drugset / Trial / NCT06078657

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

NCT06078657

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-10
Primary completion
2024-10
Completion
2025-10

Drugs

EvaluationDrugModalityDoseRoute
Subject NEGALSTOBART Monoclonal antibody 200 mg Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous