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

A Safety and Efficacy Study of CT-Guided Adaptive Radiation Therapy With Anti-PD-1 Antibody Adjuvant Immunotherapy in Patients With Thoracic Cancer (CARTAI)

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)

Study Overview

• Status: Unknown
• Conditions: Thoracic Malignancies
• Intervention / Treatment: Drug: IBI308

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Haihua Yang, MD; Phone Number: +86 13819639006; Email: yhh93181@hotmail.com
• Study Contact Backup: Name: Yinnan Meng, MD; Phone Number: +86 13486208109; Email: mengyn6484@enzemed.com

Study Locations

• China
  • Zhejiang
    • Taizhou, Zhejiang, China, 317000
      • Recruiting
      • Taizhou Hospital of Zhejiang Province
      • Contact: Haihua Yang, MD; Phone Number: +86 13819639006; Email: yhh93181@hotmail.com
      • Contact: Yinnan Meng, MD; Phone Number: +86 13486208109; Email: mengyn6484@enzemed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-PD-1 antibody; IBI308 200mg intravenous drip every three weeks following adaptive radiation therapy.	Drug: IBI308; A humanized anti-PD-1 monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs and SAEs at 6 months	Number of participants with adverse events and serious adverse events at 6 months will be measured. [CTCAE v4.03]	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate is the percentage of patients with at least once occurrence of PR or CR [RECIST v1.1]	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]	Estimated to be up to 3 years
AEs	Number of patients with acute and chronic adverse events will be measured [CTCAE v4.03]	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]	Estimated to be up to 3 years
OS	Overall Survival is the time interval from the start of treatment to death from any cause.	Estimated to be up to 3 years

Collaborators and Investigators

• Sponsor: Taizhou Hospital
• Investigators: Principal Investigator: Fengming (Spring) Kong, MD, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University; Principal Investigator: Haihua Yang, MD, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University; Principal Investigator: Yinnan Meng, MD, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: November 2, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Neoplasms; Aneurysm, Dissecting
• Other Study ID Numbers: YHH-201811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No