NCT05461794

Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma

Phase 2, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Patients With Locally Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma That Progressed on or After Anti-PD-(L)1 Antibody Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aimed to evaluate the efficacy and safety of sitravatinib in combination with tislelizumab as a second- or third-line treatment for participants with locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) who experienced disease progression following prior systemic chemotherapy.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sitravatinib	100 mg orally once daily
DRUG	Tislelizumab	200 mg intravenously once every 3 weeks
DRUG	Docetaxel	75 milligrams per square meter of body surface area (mg/m2) intravenously on Day 1 of every 21-day cycle
DRUG	Irinotecan	125 mg/m2 intravenously on Days 1 and 8 of every 21-day cycle

Timeline

• Start date: 2022-10-03
• Primary completion: 2024-02-26
• Completion: 2024-02-26
• First posted: 2022-07-18
• Last updated: 2025-06-13
• Results posted: 2025-06-13

Locations

31 sites across 1 country: China