Tislelizumab in Addition to BACE in Patients With NSCLC
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|ClinicalTrials.gov Identifier: NCT05058560|
Recruitment Status : Not yet recruiting
First Posted : September 27, 2021
Last Update Posted : September 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|NSCLC||Drug: Tislelizumab||Phase 2|
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-Ⅳ NSCLC patients who failed, refused or ineligible to receive standard treatments.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tislelizumab in Addition to Bronchial Arterial Chemoembolization in Patients With Non-Small-Cell Lung Cancer -- A Single-arm Phase II Trial|
|Estimated Study Start Date :||November 15, 2021|
|Estimated Primary Completion Date :||June 15, 2023|
|Estimated Study Completion Date :||December 15, 2023|
BACE was performed on the first day of the first cycle, and the first 200 mg of tislelizumab was given 3-5 days later.
tislelizumab, 200 mg IV Q3W, up to one year.
Other Name: Bronchial artery chemoembolization (BACE)
- Progression-free survival (PFS) [ Time Frame: 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
- 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) [ Time Frame: 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) [ Time Frame: 1 years or more ]Time from the first BACE treatment to death from any cause or the end of the study
- Quality of life score (EORTC, QLQ-30) [ Time Frame: 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 ]Changes of quality of life score; using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scores