Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure: A Prospective, Multicenter, Randomized, Open, Double-arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. All eligible patients were randomly assigned to DEB-BACE combined with PD-1 inhibitor (Sindilizumab) treatment group (test group) and DEB-BACE treatment group (control group), to explore the efficacy and safety of combination therapy for stage II/III NSCLC with standard treatment failure or intolerable patients.
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
- Single (Outcomes Assessor)
盲法说明
This study is an open-label study. The Participants and investigators are not blinded, but the outcomes assessor are blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 18 years old, no gender limit.
- •According to the Diagnosis and Treatment of Primary Lung Cancer (2018 edition), non-small cell lung cancer (NSCLC) was diagnosed by histopathology.
- •Tumor Node Metastasis (TNM) staging is II-III.
- •According to the National Comprehensive Cancer Network (NCCN) guidelines, patients who had failed, refused, or were not suitable for standard treatment (surgery, chemoradiotherapy, targeted) after consultation.
- •Eastern Cooperative Oncology Group (ECOG), Performance Status (PS) Score ≤
- •Estimated survival time is more than 3 months.
- •The patient has signed informed consent.
排除标准
- •The patient has previously received interventional therapy [iodine seed implantation, ablation, bronchial arterial chemoembolization (BACE) therapy], or received immunotherapy during the first-line standard treatment.
- •The patient is accompanied by other malignant tumors and had not been cured.
- •White blood cell < 3×10*9/L, absolute value of neutrophils < 1.5×10*9/L, neutrophil/lymphocyte ratio ≥ 3, platelet count < 50×10*9/L, hemoglobin concentration < 90 g/L.
- •Liver and kidney dysfunction (creatinine > 176.8 μmol/L; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 times the upper limit of normal).
- •Uncorrectable coagulopathy or active hemoptysis.
- •Patient with active infections requires antibiotic treatment.
- •Patient has uncontrollable hypertension, diabetes, and cardiovascular disease with obvious symptoms.
- •Allergy to contrast agents.
- •Women with pregnancy or lactation.
研究组 & 干预措施
Combination Treatment Group
Drug-eluting Beads Bronchial Arterial Chemoembolization combined with Programmed Cell Death Protein 1 Inhibitor was used for treatment.
干预措施: Drug-eluting beads bronchial arterial chemoembolization (Procedure)
Combination Treatment Group
Drug-eluting Beads Bronchial Arterial Chemoembolization combined with Programmed Cell Death Protein 1 Inhibitor was used for treatment.
干预措施: Programmed Cell Death Protein 1 Inhibitor (Drug)
Single Treatment Group
Only receive drug-eluting beads bronchial arterial chemoembolization treatment.
干预措施: Drug-eluting beads bronchial arterial chemoembolization (Procedure)
结局指标
主要结局
Progression Free Survival
时间窗: The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years.
The most common primary endpoint in cancer trials.
次要结局
- Overall Survival(Time from randomization to death from any cause, in "months", assessed up to 2 years. For patients who are still alive at the time of data analysis, OS is calculated based on the date when the patient is last known to be alive.)
- Duration of Overall Response(The time from the first assessment of the tumor as complete remission or partial remission to the first assessment as disease progression or death from any cause, assessed up to 12 months.)
- Objective Response Rate(Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria, assessed up to 12 months.)
- Pain assessment(From date of randomization to every follow-up time, assessed up to 2 years.)
- Disease Control Rate(Proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD) according to mRECIST criteria, assessed up to 12 months.)
- Eastern Cooperative Oncology Group Score(From pre-procedure to every follow-up time, assessed up to 2 years.)
- Quality of life Questionare-Core score(From date of randomization to every follow-up time, assessed up to 2 years.)
- The incidence of adverse events and serious adverse events(From date of randomization to every follow-up time, assessed up to 2 years.)
- Time to tumor untreatable progression(The time interval between randomization to tumor progression that patients are unable to further receive treatment, assessed up to 12 months.)
- Tumor biomarkers(From pre-procedure to every follow-up time, assessed up to 2 years.)
- Recurrence rate of hemoptysis(From date of randomization to every follow-up time, assessed up to 2 years.)