Tislelizumab in Addition to Bronchial Arterial Chemoembolization in Patients with Non-Small-Cell Lung Cancer -- a Single-arm Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
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-Ⅳ NSCLC patients who failed, refused or ineligible to receive standard treatments.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Expected life span > 3 months.
- •Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells
排除标准
- •Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-
- •Prior therapies of interventional therapy (I seeds implantation, Ablation, BACE).
- •Harboring EGFR sensitizing mutation or ALK gene translocation
- •History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
- •With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
- •Symptomatic central nervous system metastasis
- •Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.
- •Prior allogeneic stem cell transplantation or organ transplantation
- •Active autoimmune diseases or history of autoimmune diseases that may relapse.
- •With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications
- •Known to be hypersensitive to contrast agent;
- •Pregnant or breastfeeding women;
- •Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
BACE+Tislelizumab
BACE was performed on the first day of the first cycle, and the first 200 mg of tislelizumab was given 3-5 days later.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 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
次要结局
- Objective response rate (ORR)(2, 4, 6 months after the first BACE treatment, up to death or 12 months)
- Disease control rate (DCR)(2, 4, 6 months after the first BACE treatment, up to death or 12 months)
- Overall survival (OS)(1 years or more)
- Quality of life score (EORTC, QLQ-30)(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)
研究者
Xuhua Duan
Associate Professor
The First Affiliated Hospital of Zhengzhou University