A Phase 2/3 interventional study of PD-1 Antibody and BACE in NSCLC, sponsored by Xuhua Duan. Recruiting at 8 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by Xuhua Duan · Phase 2/3, Interventional, and Treatment
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.
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.
Xuhua Duan is the lead sponsor of 7 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Device: BACE
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
PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1
Also known as: PD-1 Inhibitors
Bronchial Arterial Chemoembolization
Progression-free survival (PFS)
Time from the first BACE treatment to either radiological progression or death
Time frame: Time from the first BACE treatment to either radiological progression or death or up to 12 months]
Objective response rate (ORR)
Proportion of patients with reduction in stable in tumor burden of a predefined amount
Time frame: 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
Time frame: 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
Time frame: 1 years
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