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

Taizhou Hospital

Status and phase: Unknown; Phase 2

Conditions: Thoracic Malignancies

Treatments: Drug: IBI308

Study type: Interventional

Funder types: Other

Identifiers

NCT03732430

YHH-201811

Details and patient eligibility

About

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)

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Anti-PD-1 antibody

Experimental group

Description:

IBI308 200mg intravenous drip every three weeks following adaptive radiation therapy.

Treatment:

Drug: IBI308