NCT06537505尚未招募2 期
An Exploratory Clinical Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Advanced Second-line and Above Solid Tumors
Beidahuang Industry Group General Hospital0 个研究点目标入组 60 人开始时间: 2024年8月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a multi-center, phase Il trial to evaluate the efficacy and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs in the treatment of advanced second-line and above solid tumors.
详细描述
This study plans to recruit 60 patients witha dvanced second-line and above solid tumors observe and evaluate the effectiveness and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with clinically confirmed advanced non-small cell lung cancer or hepatocellular carcinoma;
- •Previously received systemic treatment;
- •Expected survival period > 3 months;
- •Age: 18-75 years old, male or female;
- •ECOG PS: 0-2 points;
- •The function of important organs meets the following requirements: a) Absolute neutrophil count ≥1.5×109/L, platelet ≥90×109/L, hemoglobin ≥90g/dL; b) Bilirubin ≤3 times ULN (patients drained by retrograde technique can be included); ALT and AST ≤5 times ULN, albumin>35g/ml, prothrombin time prolonged <6 seconds; c) Creatinine <120 μmol/L, or MDRD creatinine clearance >60 mL/min;
- •Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment, and women of childbearing age and men (having sexual relations with women of childbearing age) must agree to use effective contraceptive measures uninterruptedly during treatment and for 6 months after the last treatment dose;
- •The patient voluntarily joined this study and signed the informed consent form.
排除标准
- •Patients who have had other malignant tumors in the past or at the same time within 5 years, but excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial or non-invasive bladder cancer, etc.
- •Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term;
- •Patients with severe pulmonary fibrosis and pulmonary hypertension;
- •Patients with infectious and radioactive inflammation around the lesion and skin infection at the puncture site that is not well controlled;
- •Systemic infection, high fever >38.5 ℃;
- •Severe anemia, dehydration and severe nutritional metabolism disorder that cannot be corrected or improved in a short period of time;
- •Poorly controlled malignant pleural effusion;
- •Uncontrolled, symptomatic brain metastasis or a history of difficult-to-control mental illness or severe intellectual or cognitive impairment;
- •Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only requires hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;
- •Congestive heart failure, uncontrollable arrhythmias, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;
- •Patients who cannot comply with the trial protocol or cannot cooperate with follow-up;
- •History of psychotropic drug abuse, alcoholism or drug abuse;
- •Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive;
- •Those who are considered by the researchers to be unsuitable for participation in this trial.
研究组 & 干预措施
microwave ablation combined with immunotherapy and anti-angiogenic drugs
Experimental
microwave ablation combined with adebrelimab and apatinib
干预措施: Adebrelimab (Drug)
microwave ablation combined with immunotherapy and anti-angiogenic drugs
Experimental
microwave ablation combined with adebrelimab and apatinib
干预措施: Apatinib (Drug)
microwave ablation combined with immunotherapy and anti-angiogenic drugs
Experimental
microwave ablation combined with adebrelimab and apatinib
干预措施: microwave ablation (Procedure)
microwave ablation combined with immunotherapy
Experimental
microwave ablation combined with adebrelimab
干预措施: Adebrelimab (Drug)
microwave ablation combined with immunotherapy
Experimental
microwave ablation combined with adebrelimab
干预措施: microwave ablation (Procedure)
结局指标
主要结局
Objective Response Rate
时间窗: up to 24 months
Determined using RECIST V1.1 criteria, defined as best overall response (CR or PR)
次要结局
- incidence rate of AE(up to 36 months)
- Overall Survival(up to 36 months)
- Disease control rate(up to 24 months)
- Progression-free Survival(up to 36 months)
研究者
LiuMingyang
Associate Chief Physician
Beidahuang Industry Group General Hospital
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