PD-1 Antibody in Addition to BACE in Patients With NSCLC: A Randomised Controlled Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization 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
PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1
Other Names:
Device: BACE
Bronchial Arterial Chemoembolization
|
| Active Comparator: Bronchial Arterial Chemoembolization 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
Bronchial Arterial Chemoembolization
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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.
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Expected life span > 3 months.
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Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells
Exclusion Criteria:
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Prior treatment targeting PD-1, PD-L1 or CTLA-4.
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Prior therapies of interventional therapy (I seed implantation, Ablation, BACE).
-
Harboring EGFR sensitizing mutation or ALK gene translocation
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History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
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With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
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Symptomatic central nervous system metastasis
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Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.
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Prior allogeneic stem cell transplantation or organ transplantation
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Active autoimmune diseases or history of autoimmune diseases that may relapse.
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With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications
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Known to be hypersensitive to contrast agent;
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Pregnant or breastfeeding women;
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Other protocol defined Inclusion/Exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | People's Hospital of Kaiyang County | Guiyang | Guizhou | China | |
| 2 | North China University of Science and Technology Affiliated Hospital | Tangshan | Hebei | China | |
| 3 | The Second Affiliated Hospital of Xingtai Medical College | Xingtai | Hebei | China | |
| 4 | Hebi City Jun County People's Hospital | Hebi | Henan | China | |
| 5 | Wuyang County People's Hospital | Luohe | Henan | China | |
| 6 | Dengzhou People's Hospital | Nanyang | Henan | China | |
| 7 | The Fifth People's Hospital of Puyang City | Puyang | Henan | China | |
| 8 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China | 450000 |
Sponsors and Collaborators
- Xuhua Duan
Investigators
- Principal Investigator: Xuhua Duan, The First Affiliated Hospital of Zhengzhou University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20221030