Trial Title:
PD-1 Antibody in Addition to BACE in Patients With NSCLC: A Randomised Controlled Trial
NCT ID:
NCT05605613
Condition:
NSCLC
Conditions: Official terms:
Immune Checkpoint Inhibitors
Antibodies
Conditions: Keywords:
BACE
PD-1 Antibody
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PD-1 Antibody
Description:
PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity
and binding specificity for PD-1
Arm group label:
PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization
Other name:
PD-1 Inhibitors
Intervention type:
Device
Intervention name:
BACE
Description:
Bronchial Arterial Chemoembolization
Arm group label:
Bronchial Arterial Chemoembolization
Arm group label:
PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
People's Hospital of Kaiyang County
Address:
City:
Guiyang
Country:
China
Status:
Recruiting
Contact:
Last name:
ShengHai Liang
Facility:
Name:
North China University of Science and Technology Affiliated Hospital
Address:
City:
Tangshan
Country:
China
Status:
Recruiting
Contact:
Last name:
Shiqi Zhou
Facility:
Name:
The Second Affiliated Hospital of Xingtai Medical College
Address:
City:
Xingtai
Country:
China
Status:
Recruiting
Contact:
Last name:
Shusen Li
Facility:
Name:
Hebi City Jun County People's Hospital
Address:
City:
Hebi
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanbing Zhang
Facility:
Name:
Wuyang County People's Hospital
Address:
City:
Luohe
Country:
China
Status:
Recruiting
Contact:
Last name:
Chenguang Pang
Facility:
Name:
Dengzhou People's Hospital
Address:
City:
Nanyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanliang Li
Facility:
Name:
The Fifth People's Hospital of Puyang City
Address:
City:
Puyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Liuan Sun
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuhua Duan
Phone:
+8613523402912
Email:
xuhuaduan@163.com
Start date:
October 29, 2022
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Xuhua Duan
Agency class:
Other
Source:
The First Affiliated Hospital of Zhengzhou University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05605613
