Overview
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.
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.
Eligibility
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