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)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
A humanized anti-PD-1 monoclonal antibody
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
RECRUITINGAEs and SAEs at 6 months
Number of participants with adverse events and serious adverse events at 6 months will be measured. \[CTCAE v4.03\]
Time frame: 6 months
ORR
Objective response rate is the percentage of patients with at least once occurrence of PR or CR \[RECIST v1.1\]
Time frame: Estimated to be up to 3 years
DoR
Duration of response is the time interval from first occurrence of PR or CR until PD or death \[RECIST v1.1\]
Time frame: Estimated to be up to 3 years
AEs
Number of patients with acute and chronic adverse events will be measured \[CTCAE v4.03\]
Time frame: Estimated to be up to 3 years
PFS
Progression-Free-Survival is the time interval from the start of treatment until disease progression or death by any cause \[RECIST v1.1\]
Time frame: Estimated to be up to 3 years
OS
Overall Survival is the time interval from the start of treatment to death from any cause.
Time frame: Estimated to be up to 3 years
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