NSCLC
Conditions
Keywords
BACE, PD-1 Antibody
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.
Interventions
DRUGPD-1 Antibody
PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1
DEVICEBACE
Bronchial Arterial Chemoembolization
Sponsors
Xuhua Duan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient age between 18 and 75 2. Signed Informed Consent Form. 3. 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 4. Adequate hematologic and end-organ function. 5. Expected life span \> 3 months. 6. Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells
Exclusion criteria
1. Prior treatment targeting PD-1, PD-L1 or CTLA-4. 2. Prior therapies of interventional therapy (I seed implantation, Ablation, BACE). 3. Harboring EGFR sensitizing mutation or ALK gene translocation 4. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline. 5. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment. 6. Symptomatic central nervous system metastasis 7. Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment. 8. Prior allogeneic stem cell transplantation or organ transplantation 9. Active autoimmune diseases or history of autoimmune diseases that may relapse. 10. With conditions requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications 11. Known to be hypersensitive to contrast agent; 12. Pregnant or breastfeeding women; 13. Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactXuHua Duan
Outcome results
None listed