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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-â…£ NSCLC patients who failed, refused or ineligible to receive standard treatments.
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-â…£ NSCLC patients who failed, refused or ineligible to receive standard treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization | Experimental | 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. |
|
| Bronchial Arterial Chemoembolization | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 Antibody | Drug | PD-1 Antibody, an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1 |
|
| 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] |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XuHua Duan | Contact | +8613523402912 | xuhuaduan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuhua Duan | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Kaiyang County | Recruiting | Guiyang | Guizhou | China |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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|
| BACE | Device | Bronchial Arterial Chemoembolization |
|
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 |
| North China University of Science and Technology Affiliated Hospital | Recruiting | Tangshan | Hebei | China |
|
| The Second Affiliated Hospital of Xingtai Medical College | Recruiting | Xingtai | Hebei | China |
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| Hebi City Jun County People's Hospital | Recruiting | Hebi | Henan | China |
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| Wuyang County People's Hospital | Recruiting | Luohe | Henan | China |
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| Dengzhou People's Hospital | Recruiting | Nanyang | Henan | China |
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| The Fifth People's Hospital of Puyang City | Recruiting | Puyang | Henan | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
|
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |