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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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NSCLC

Intervention / Treatment
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* Drug: PD-1 Antibody
* Device: BACE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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; Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization<br>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<br>* PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1<br>* Other names: PD-1 Inhibitors;Device: BACE<br>* Bronchial Arterial Chemoembolization<br>|
| Active Comparator: Bronchial Arterial Chemoembolization<br>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<br>* Bronchial Arterial Chemoembolization<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BACE, PD-1 Antibody