PD-1 Antibody in Addition to BACE in Patients With NSCLC: A Randomised Controlled Trial
1 other identifier
interventional
150
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2022
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 29, 2022
CompletedFirst Submitted
Initial submission to the registry
October 31, 2022
CompletedFirst Posted
Study publicly available on registry
November 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedNovember 9, 2022
November 1, 2022
1 year
October 31, 2022
November 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Objective response rate (ORR)
Time Frame: 2, 4, 6 months after the first BACE treatment, up to death or 12 months
Disease control rate (DCR)
2, 4, 6 months after the first BACE treatment, up to death or 12 months
Overall survival (OS)
1 years
Study Arms (2)
PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization
EXPERIMENTALTreated 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.
Bronchial Arterial Chemoembolization
ACTIVE COMPARATORBronchial 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
Interventions
PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1
Bronchial Arterial Chemoembolization
Eligibility Criteria
You may qualify if:
- Patient age between 18 and 75
- Signed Informed Consent Form.
- 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
- Adequate hematologic and end-organ function.
- Expected life span \> 3 months.
- Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells
You may not qualify if:
- Prior treatment targeting PD-1, PD-L1 or CTLA-4.
- Prior therapies of interventional therapy (I seed implantation, Ablation, BACE).
- Harboring EGFR sensitizing mutation or ALK gene translocation
- History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
- With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
- Symptomatic central nervous system metastasis
- Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.
- Prior allogeneic stem cell transplantation or organ transplantation
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- With conditions requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications
- Known to be hypersensitive to contrast agent;
- Pregnant or breastfeeding women;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xuhua Duanlead
Study Sites (8)
People's Hospital of Kaiyang County
Guiyang, Guizhou, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, China
Hebi City Jun County People's Hospital
Hebi, Henan, China
Wuyang County People's Hospital
Luohe, Henan, China
Dengzhou People's Hospital
Nanyang, Henan, China
The Fifth People's Hospital of Puyang City
Puyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xuhua Duan
The First Affiliated Hospital of Zhengzhou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 31, 2022
First Posted
November 4, 2022
Study Start
October 29, 2022
Primary Completion
November 15, 2023
Study Completion
December 1, 2025
Last Updated
November 9, 2022
Record last verified: 2022-11