A Safety and Efficacy Study of CT-Guided Adaptive Radiation Therapy With Anti-PD-1 Antibody Adjuvant Immunotherapy in Patients With Thoracic Cancer (CARTAI)
Overview
- Phase
- Phase 2
- Intervention
- IBI308
- Conditions
- Thoracic Malignancies
- Sponsor
- Taizhou Hospital
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- AEs and SAEs at 6 months
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Haihua Yang
Head of Department of Radiation Oncology, Chief Physician
Taizhou Hospital
Eligibility Criteria
Inclusion Criteria
- •Signed inform consent form
- •Age \>= 18 years and \<= 75 years
- •Histologically or cytologically confirmed advanced/metastatic thoracic malignancies
- •Patients must receive adaptive radiation therapy within 45 days before the first dose of trial treatment
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Life expectancy \>= 8 weeks
- •Adequate hematologic and end organ function
Exclusion Criteria
- •Prior exposure to any immune checkpoint inhibitors including but not limited to anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies.
- •Prior exposure to any other thoracic radiation therapy before this time radiation therapy.
- •Prior exposure to steroid therapy or any other form of immunosuppressive therapy within 14 days before the first dose of trial treatment
- •No active second cancers
- •Active or prior autoimmune disease or immunodeficiency.
- •Active infections including but not limited to hepatitis B, C ,and HIV.
- •Significant cardiovascular disease
- •Active or untreated central nervous system (CNS) metastases
- •Any unresolved toxicity CTCAE \>= Grade 3 from the prior radiation therapy.
- •Known hypersensitivity to humanized antibodies or fusion proteins or any of study drug excipients.
Arms & Interventions
Anti-PD-1 antibody
IBI308 200mg intravenous drip every three weeks following adaptive radiation therapy.
Intervention: IBI308
Outcomes
Primary Outcomes
AEs and SAEs at 6 months
Time Frame: 6 months
Number of participants with adverse events and serious adverse events at 6 months will be measured. \[CTCAE v4.03\]
Secondary Outcomes
- ORR(Estimated to be up to 3 years)
- DoR(Estimated to be up to 3 years)
- AEs(Estimated to be up to 3 years)
- PFS(Estimated to be up to 3 years)
- OS(Estimated to be up to 3 years)