NCT03811379

Toripalimab as Monotherapy for Patients With Small Cell Carcinoma of Esophagus Who Failed Chemotherapy

Phase II Clinical Trial of Toripalimab (JS001), a Recombinant Humanized Anti-PD-1 Monoclonal PD1 Antibody, as Monotherapy for Patients With Small Cell Esophageal Carcinoma Who Failed Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the anti-tumor activity, safety and tolerance of toripalimab as monotherapy for patients with small cell esophageal cancer (SCCE), and to explore the potential biomarkers for this treatment.

Detailed description

For the first time in the world, the investigators revealed the genomic characteristics of SCCE and constructed a complete genomic profile of SCCE. The analysis of transcriptome data showed that the number of effector T cells in SCCE immune microenvironment was significantly higher than that of other cancers, and NK cells were relatively high. Macrophages in SCCE mainly showed M2-like phenotype and maintained at a relatively high level, suggesting the possibility of immunotherapy in SCCE treatment. Therefore, the purpose of this study is to clarify the efficacy of PD-1 antibody in the treatment of patients with SCCE who failed chemotherapy, so as to provide a basis for further large-scale clinical research.

Conditions

• Small Cell Carcinoma of Esophagus
• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab	Drug: Toripalimab, 240mg, every 3 weeks until disease progress or intolerable toxicity

Timeline

• Start date: 2018-11-21
• Primary completion: 2020-12-30
• Completion: 2021-12-30
• First posted: 2019-01-22
• Last updated: 2019-01-23

Locations

1 site across 1 country: China