NCT05049681

Study of Anti-PD-1 Antibody SHR-1210 Plus Apatinib vs SHR-1210 as Second-Line Treatment of Advanced Esophageal Squamous Cell

Anti-PD-1 Antibody SHR-1210 Combined With Apatinib Versus SHR-1210 in the Second-line Treatment of Advanced Esophageal Squamous Cell Carcinoma：A Multicentre，Randomized， Open Label，Phase 3 Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Feng Wang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of Anti-PD-1 antibody SHR-1210 plus apatinib versus SHR-1210 as second-line treatment of advanced esophageal squamous cell.

Detailed description

The incidence of esophageal cancer is ranked seventh in the world, and the mortality rate ranks sixth in the world. At present, the first-line treatment of advanced esophageal cancer is mainly based on the combination of paclitaxel, cisplatin and fluorouracil. After the failure of first-line treatment, there is no standard second-line treatment. Recently the study of KEYNOTE181, ATTRACTION-3 and ESCORT had confirmed that PD-1 single drug in the second-line treatment of esophageal cancer is better than the previous traditional chemotherapy, and has become a new standard treatment. In order to further improve the therapeutic efficacy and prognosis of advanced esophageal squamous cell carcinoma, we designed this phase III clinical study to compare the efficacy and safety of shr-1210 combined with apatinib and shr-1210 in the second-line treatment of esophageal squamous cell carcinoma.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab	SHR-1210（Camrelizumab） 200 mg，Intravenous injection， q2W ，A course of treatment need 28 days.
DRUG	Apatinib	Apatinib 250mg, q.d.po

Timeline

• Start date: 2021-12-05
• Primary completion: 2022-12-20
• Completion: 2023-06-30
• First posted: 2021-09-20
• Last updated: 2021-09-20