NCT04797507

SHR-1210 in Combination With Anlotinib in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer

SHR-1210, a Novel Anti-PD-1 Antibody, in Combination With Anlotinib As Second-line or Above Treatment in Patients With Advanced or Metastatic Esophageal Squamous Cell Cancer: a Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to explore the clinical efficacy of SHR-1210 in combined with Anlotinib in the treatment of second- or above- line advanced or metastatic esophageal squamous cell cancer patients, in order to find a better therapy strategy for esophageal squamous cell cancer patients.

Detailed description

This is a prospective, phase II, single-arm clinical trial. Advanced or metastatic esophageal squamous cell cancer(ESCC) patients progressed after 1st systematic treatment are treated with SHR-1210 and Anlotinib. SHR-1210 was given intravenously(200mg d1 Q2w), combined with Anlotinib orally, 12 mg d1-14 Q3w. The hypothesis: The objective response rate in SHR-1210 combined with Anlotinib can reach 40% as second-line or above treatment of advanced or metastatic ESCC patients. The primary endpoint is objective response rate (ORR) and the secondary endpoint is disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and safety of this regimen.

Conditions

• SHR-1210
• Anlotinib
• Advanced Esophageal Squamous Cell Cancer

Interventions

Type	Name	Description
DRUG	SHR-1210 plus Anlotinib	SHR-1210: a novel anti-PD-1 antibody Anlotinib: a multi-kinase inhibitor

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2021-03-15
• Last updated: 2021-03-15