NCT03732430

CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients

A Safety and Efficacy Study of CT-Guided Adaptive Radiation Therapy With Anti-PD-1 Antibody Adjuvant Immunotherapy in Patients With Thoracic Cancer (CARTAI)

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

Summary

This phase II study is to evaluate the safety and efficacy of CT-based adaptive radiation therapy followed by adjuvant anti-PD-1 antibody immunotherapy in treating patients with different types and stages of thoracic malignancies. (CARTAI)

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety and toxicity of anti-programmed cell death 1 (PD-1) inhibition consolidation therapy after radiation therapy for multiple thoracic malignancies. SECONDARY OBJECTIVES: I. To assess the efficacy of adjuvant anti-PD-1 antibody immunotherapy after radiotherapy. II. To understand the dynamics and interactions of IDO with others immune pathway biomarkers. III. To evaluate whether IDO immune status could predict the treatment outcomes of radiation and immune combined therapy.

Conditions

• Thoracic Malignancies

Interventions

Type	Name	Description
DRUG	IBI308	A humanized anti-PD-1 monoclonal antibody

Timeline

• Start date: 2018-11-14
• Primary completion: 2020-12-31
• Completion: 2022-05-31
• First posted: 2018-11-06
• Last updated: 2018-11-29

Locations

1 site across 1 country: China