PD-1 Antibody in Addition to BACE in Patients With NSCLC: A Randomised Controlled Trial
- Conditions
- NSCLC
- Interventions
- Device: BACEDrug: PD-1 Antibody
- Registration Number
- NCT05605613
- Lead Sponsor
- Xuhua Duan
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bronchial Arterial Chemoembolization 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 PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization PD-1 Antibody 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. PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization BACE 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.
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) Time from the first BACE treatment to either radiological progression or death or up to 12 months] Time from the first BACE treatment to either radiological progression or death
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) Time Frame: 2, 4, 6 months after the first BACE treatment, up to death or 12 months Proportion of patients with reduction in stable in tumor burden of a predefined amount
Disease control rate (DCR) 2, 4, 6 months after the first BACE treatment, up to death or 12 months Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
Overall survival (OS) 1 years ime from the first BACE treatment to death from any cause or the end of the study
Trial Locations
- Locations (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
Dengzhou People's Hospital
🇨🇳Nanyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Wuyang County People's Hospital
🇨🇳Luohe, Henan, China
The Fifth People's Hospital of Puyang City
🇨🇳Puyang, Henan, China