Clinical trial NCT03732430: CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients
Official title: A Safety and Efficacy Study of CT-Guided Adaptive Radiation Therapy With Anti-PD-1 Antibody Adjuvant Immunotherapy in Patients With Thoracic Cancer (CARTAI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thoracic Malignancies
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Signed inform consent form
2. Age \>= 18 years and \<= 75 years
3. Histologically or cytologically confirmed advanced/metastatic thoracic malignancies
4. Patients must receive adaptive radiation therapy within 45 days before the first dose of trial treatment
5. Eastern Cooperative Oncology Group performance status of 0 or 1
6. Life expectancy \>= 8 weeks
7. Adequate hematologic and end organ function

Exclusion Criteria:

1. Prior exposure to any immune checkpoint inhibitors including but not limited to anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies.
2. Prior exposure to any other thoracic radiation therapy before this time radiation therapy.
3. Prior exposure to steroid therapy or any other form of immunosuppressive therapy within 14 days before the first dose of trial treatment
4. No active second cancers
5. Active or prior autoimmune disease or immunodeficiency.
6. Active infections including but not limited to hepatitis B, C ,and HIV.
7. Significant cardiovascular disease
8. Active or untreated central nervous system (CNS) metastases
9. Any unresolved toxicity CTCAE \>= Grade 3 from the prior radiation therapy.
10. Known hypersensitivity to humanized antibodies or fusion proteins or any of study drug excipients.
11. Known psychiatric or physical impairments that would interfere with cooperation with the protocol of this trial.

Primary outcomes:
measure: AEs and SAEs at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: ORR
timeFrame: Estimated to be up to 3 years
measure: DoR
timeFrame: Estimated to be up to 3 years
measure: AEs
timeFrame: Estimated to be up to 3 years
measure: PFS
timeFrame: Estimated to be up to 3 years
measure: OS
timeFrame: Estimated to be up to 3 years
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Fengming (Spring) Kong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Haihua Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Yinnan Meng, MD
role: PRINCIPAL_INVESTIGATOR
References: