PD-1 Antibody in Addition to BACE in Patients With NSCLC: A Randomised Controlled Trial

PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization in Patients With Non-Small-Cell Lung Cancer: A Randomised Controlled Trial

This is a randomized controlled trial to determine the efficacy and safety of PD-1 Antibody in addition to Bronchial Arterial Chemoembolization in stage III-Ⅳ NSCLC patients who failed, refused or ineligible to receive standard treatments.

Study Overview

• Status: Recruiting
• Conditions: NSCLC
• Intervention / Treatment: Drug: PD-1 Antibody; Device: BACE

Detailed Description

Bronchial artery chemoembolization (BACE) is a technique of drug delivery and embolization performed via injecting anti-tumor drugs with drug carriers and implanting the embolization agents into the tumor feeding artery, promoting the clinical outcomes of patients and providing a palliative treatment option for patients with NSCLC. while the short-term effect of BACE is good, it is easy to relapse and metastasize.

The rapid development of immunotherapy checkpoint inhibitors represented by PD-1/L1 monoclonal antibody has changed the treatment pattern of NSCLC. The publication of early research data repeatedly verified the long-term survival benefit characteristics of PD-1/L1 in NSCLC.

Based on this research and clinical practice, we designed this trial to determine the efficacy and safety of PD-1 antibody in addition to Bronchial Arterial Chemoembolization in stage III-Ⅳ NSCLC patients who failed, refused or ineligible to receive standard treatments.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Xuhua Duan; Phone Number: +8613523402912; Email: xuhuaduan@163.com

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • People's Hospital of Kaiyang County
      • Contact: ShengHai Liang
  • Hebei
    • Tangshan, Hebei, China
      • Recruiting
      • North China University of Science and Technology Affiliated Hospital
      • Contact: Shiqi Zhou
    • Xingtai, Hebei, China
      • Recruiting
      • The Second Affiliated Hospital of Xingtai Medical College
      • Contact: Shusen Li
  • Henan
    • Hebi, Henan, China
      • Recruiting
      • Hebi City Jun County People's Hospital
      • Contact: Yanbing Zhang
    • Luohe, Henan, China
      • Recruiting
      • Wuyang County People's Hospital
      • Contact: Chenguang Pang
    • Nanyang, Henan, China
      • Recruiting
      • Dengzhou People's Hospital
      • Contact: Yanliang Li
    • Puyang, Henan, China
      • Recruiting
      • The Fifth People's Hospital of Puyang City
      • Contact: Liuan Sun
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Xuhua Duan; Phone Number: +8613523402912; Email: xuhuaduan@163.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. Patient age between 18 and 75
2. Signed Informed Consent Form.
3. Confirmed TNM stage is III-Ⅳ of NSCLC ，and failed, refused or assessed ineligible to receive conventional treatments (surgery, chemoradiotherapy, chemotherapy )； Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
4. Adequate hematologic and end-organ function.
5. Expected life span > 3 months.
6. Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells

Exclusion Criteria:

1. Prior treatment targeting PD-1, PD-L1 or CTLA-4.
2. Prior therapies of interventional therapy (I seed implantation, Ablation, BACE).
3. Harboring EGFR sensitizing mutation or ALK gene translocation
4. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
5. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
6. Symptomatic central nervous system metastasis
7. Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.
8. Prior allogeneic stem cell transplantation or organ transplantation
9. Active autoimmune diseases or history of autoimmune diseases that may relapse.
10. With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications
11. Known to be hypersensitive to contrast agent;
12. Pregnant or breastfeeding women;
13. Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization; Treated with BACE and PD-1 antibody as induction therapy during which BACE was performed on the first day and PD-1 antibody was given 3-5 days later, then PD-1 antibody was administered at 200mg Q3W as maintenance therapy.	Drug: PD-1 Antibody; PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1; Other Names: PD-1 Inhibitors; Device: BACE; Bronchial Arterial Chemoembolization
Active Comparator: Bronchial Arterial Chemoembolization; Bronchial artery chemoembolization (BACE) is a technique of drug delivery and embolization performed via injecting anti-tumor drugs with drug carriers and implanting the embolization agents into the tumor feeding artery	Device: BACE; Bronchial Arterial Chemoembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Time from the first BACE treatment to either radiological progression or death	Time from the first BACE treatment to either radiological progression or death or up to 12 months]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Proportion of patients with reduction in stable in tumor burden of a predefined amount	Time Frame: 2, 4, 6 months after the first BACE treatment, up to death or 12 months
Disease control rate (DCR)	Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount	2, 4, 6 months after the first BACE treatment, up to death or 12 months
Overall survival (OS)	ime from the first BACE treatment to death from any cause or the end of the study	1 years

Collaborators and Investigators

• Sponsor: Xuhua Duan
• Investigators: Principal Investigator: Xuhua Duan, The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2022
• Primary Completion (Anticipated): November 15, 2023
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: PD-1 Antibody; BACE
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Antibodies; Immune Checkpoint Inhibitors
• Other Study ID Numbers: 20221030

Drug and device information, study documents

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