NCT03766178

Study of Anti-PD-1 Antibody SHR-1210 Plus Nimotuzumab in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

A Single-arm, Open Phase II Clinical Trial of Anti-PD-1 Antibody SHR-1210 Combined With Nimotuzumab as Second-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of anti-PD-1 antibody SHR-1210 combined with nimotuzumab as second-line therapy in patients with advanced cancerous esophageal squamous cell carcinoma.

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. The investigators designed a single-arm, open phase II clinical trial of anti-PD-1 antibody SHR-1210 combined with nimotuzumab as second-line therapy in patients with advanced cancerous esophageal squamous cell carcinoma.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nimotuzumab + SHR-1210	SHR-1210: 200 mg/time, intravenous injection, q2W continuous medication, a course of treatment needs 28 days. The cumulative longest medication period is 2 years. Nimotuzumab: 200 mg/time, intravenous injection, administered on the 1st and 8th days of each cycle, every 2 weeks is one cycle.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-12-01
• Completion: 2023-09-01
• First posted: 2018-12-06
• Last updated: 2021-07-07

Locations

1 site across 1 country: China