NCT04813406

Study of Anlotinib Plus Sintilimab in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

Anlotinib in Combination With Sintilimab as Second-line Treatment for Advanced Esophageal Squamous Cell Carcinoma (ESCC) : a Multicenter, Single-arm, Open-label Phase Ⅱ Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Henan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of anlotinib combined with sindilimab as second-line treatment for advanced esophageal squamous cell carcinoma (ESCC). In addition, we also explored the possible mechanism of anlotinib combined with sindilimab in order to screen out biomarkers that can predict the efficacy of the combination therapy.

Detailed description

China is one of the regions with the highest risk of esophageal cancer in the world, and more than 90% of esophageal cancer is squamous cell carcinoma (SCC). The incidence of esophageal cancer is ranked sixth and the mortality rate ranks fourth in China. 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 multicenter, single-arm, open-label phase Ⅱ clinical trial of anlotinib combined with sindilimab as second-line treatment for advanced esophageal squamous cell carcinoma (ESCC).

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Anlotinib + Sintilimab	Anlotinib: 1 capsule (10mg) once a day, d1-d14 per cycle, 3 weeks for a treatment cycle. Sintilimab: 200 mg/time, intravenous injection, every 3 weeks is one cycle.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2021-03-24
• Last updated: 2021-03-24