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This is a single-arm phase II trial to determine the efficacy and safety of Tislelizumab 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.
Tislelizumab is an investigational humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1. Tislelizumab was engineered to minimize binding to FcγR on macrophages in order to limit antibody-dependent phagocytosis, a potential mechanism of resistance to anti-PD-1 therapy. Tislelizumab in combination with platinum-based chemotherapy as first-line treatment for advanced SCLC and NSCLC, including nsq-NSCLC, resulted in robust responses in a phase 2 study (BGB-A317-206 [NCT03432598]), In phase 3 study, addition of tislelizumab to chemotherapy resulted in significantly improved progression-free survival (PFS) compared with chemotherapy alone in patients with stage IIIB or IV squamous NSCLC (RATIONALE 307; BGB-A317-307 [NCT03594747]) and nsq-NSCLC (RATIONALE 304; BGB-A317-304 [NCT03663205]). Second-and third-line tislelizumab monotherapy prolonged OS in the ITT and PD-L1 ≥ 25% populations vs docetaxel in patients with advanced NSCLC(RATIONALE 303; BGB-A317-303 [NCT03358875]). China NMPA have approved for tislelizumab + chemotherapy for 1L NSCLC.
This trial is designed to determine the efficacy and safety of Tislelizumab 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 |
|---|---|---|---|
| BACE+Tislelizumab | Experimental | BACE was performed on the first day of the first cycle, and the first 200 mg of tislelizumab was given 3-5 days later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | tislelizumab, 200 mg IV Q3W, up to one year. |
|
| 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 | 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 | Affiliation | Role |
|---|---|---|
| Xuhua Duan | Zhengzhou University - First Affiliated Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Hennan | 450000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41548595 | Derived | Liang C, Han D, Li H, Wang M, Kuang D, Chen H, Miao H, Chen P, Lu H, Jiao P, Ren J, Han X, Li F, Duan X. Bronchial Arterial Chemoembolization Combined with Tislelizumab for Non-Small Cell Lung Cancer: An Exploratory, Prospective, Single-Arm, Phase II Trial. J Vasc Interv Radiol. 2026 Apr;37(4):108001. doi: 10.1016/j.jvir.2026.108001. Epub 2026 Jan 16. |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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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) | Time from the first BACE treatment to death from any cause or the end of the study | 1 years or more |
| Quality of life score (EORTC, QLQ-30) | Changes of quality of life score; using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scores | Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 12 months |