NCT04065737

Sintilimab to Prevent High-risk Oral Premalignant Lesions Cancerization

A Phase II Open-label, Single Arm Study to Evaluate the Efficacy of Sintilimab(IBI 308) to Prevent High-risk Oral Premalignant Lesions Cancerization

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized, phase II, open-label study. The goal of this clinical research study is to investigate how well sintilimab works in preventing high-risk oral premalignant lesions cancerization.

Detailed description

this study is a non-randomized, phase II, open-label study. Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether it works in preventing or treating a disease. the purpose of this study is to evaluate the effectiveness of sintilimab in preventing the onset of oral cancer in patients with high-risk oral premalignant lesions, who had oral cancer at least once before.

Conditions

• Oral Cavity Cancer
• Mouth Neoplasm
• Precancerous Conditions

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells. other name: IBI308

Timeline

• Start date: 2019-08-15
• Primary completion: 2022-07-15
• Completion: 2022-12-30
• First posted: 2019-08-22
• Last updated: 2019-08-22

Locations

1 site across 1 country: China