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

NCT03732430 | Unknown Phase 2

• 1 other identifier: YHH-201811
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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)

Conditions

Thoracic Malignancies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Anti-PD-1 antibody

EXPERIMENTAL

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

Drug: IBI308

Interventions

IBI308 DRUG

A humanized anti-PD-1 monoclonal antibody

Anti-PD-1 antibody

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Known psychiatric or physical impairments that would interfere with cooperation with the protocol of this trial.

Sponsors & Collaborators

• Taizhou Hospital: lead

Study Sites (1)

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China

RECRUITING

MeSH Terms

Interventions

sintilimab

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haihua Yang, MD

CONTACT

+86 13819639006; yhh93181@hotmail.com

Yinnan Meng, MD

CONTACT

+86 13486208109; mengyn6484@enzemed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Radiation Oncology, Chief Physician

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 6, 2018
• Study Start: November 14, 2018
• Primary Completion: December 31, 2020
• Study Completion: May 31, 2022
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)