PD-1 Antibody in Addition to Bronchial Arterial Chemoembolization in Patients With Non-Small-Cell Lung Cancer: A Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
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.
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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 treatment targeting PD-1, PD-L1 or CTLA-
- •Prior therapies of interventional therapy (I seed 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
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.
干预措施: PD-1 Antibody (Drug)
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.
干预措施: BACE (Device)
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
干预措施: BACE (Device)
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)(Time Frame: 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)
研究者
Xuhua Duan
Associate Professor
The First Affiliated Hospital of Zhengzhou University