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

Phase 2

• Conditions: Thoracic Malignancies
• Interventions: Drug: IBI308

• Registration Number: NCT03732430
• Lead Sponsor: Taizhou Hospital

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.

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-02
• Study First Submitted QC: 2018-11-05
• Study First Posted: 2018-11-06
• Study Start: 2018-11-14
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-29
• Primary Completion: 2020-12-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-PD-1 antibody	IBI308	IBI308 200mg intravenous drip every three weeks following adaptive radiation therapy.

Primary Outcome Measures

Name	Time	Method
AEs and SAEs at 6 months	6 months	Number of participants with adverse events and serious adverse events at 6 months will be measured. \[CTCAE v4.03\]

Secondary Outcome Measures

Name	Time	Method
ORR	Estimated to be up to 3 years	Objective response rate is the percentage of patients with at least once occurrence of PR or CR \[RECIST v1.1\]
DoR	Estimated to be up to 3 years	Duration of response is the time interval from first occurrence of PR or CR until PD or death \[RECIST v1.1\]
AEs	Estimated to be up to 3 years	Number of patients with acute and chronic adverse events will be measured \[CTCAE v4.03\]
PFS	Estimated to be up to 3 years	Progression-Free-Survival is the time interval from the start of treatment until disease progression or death by any cause \[RECIST v1.1\]
OS	Estimated to be up to 3 years	Overall Survival is the time interval from the start of treatment to death from any cause.

Trial Locations

Locations (1)

Taizhou Hospital of Zhejiang Province; 🇨🇳 Taizhou, Zhejiang, China