NCT06306560尚未招募2 期
An Exploratory Clinical Study of Adebrelimab in Combination With Famitinib and Chemotherapy for the Treatment of First-line Extensive Stage Small Cell Lung Cancer
Harbin Medical University0 个研究点目标入组 40 人开始时间: 2024年3月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- 6-month progression-free survival
研究概览
简要总结
This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer.
详细描述
This study plans to recruit 40 patients with extensive-stage small cell lung disease who have not received treatment, observe and evaluate the effectiveness and safety of adebrelimab combined with famitinib and chemotherapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years old, male or female
- •Patients with pathologically confirmed extensive stage small cell lung cancer (according to the Veterans Administration Lung Study Group, VALG staging)
- •Never received prior systemic therapy for extensive stage small cell lung cancer
- •Have a measurable tumour target lesion (meeting RECIST 1.1 criteria)
- •Expected survival > 3 months
- •ECOG PS: 0-1 points
- •Normal function of major organs
- •Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose
- •Patients voluntarily enrolled in this study by signing an informed consent form
排除标准
- •Previous or concurrent other malignant tumours within 5 years, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial or non-invasive bladder cancer
- •Active tuberculosis infection, or a history of previous tuberculosis infection
- •Uncontrolled, symptomatic brain metastases that are not effectively controlled or a history of psychiatric illness that cannot be easily controlled or severe intellectual or cognitive dysfunction
- •Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment
- •Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage
- •Subjects with the presence of any severe and/or uncontrolled disease
- •Imaging showing tumour invasion of large vessels or poor demarcation from large vessels
- •Susceptibility to bleeding, risk of hemoptysis, and history of significant coagulation disorders
- •History of psychotropic substance abuse, alcoholism or drug addiction
- •Active hepatitis (Hepatitis B reference: HBsAg positive with HBV DNA test value exceeding the upper limit of normal value Hepatitis C reference HCV antibody positive with HCV viral titre test value exceeding the upper limit of normal value)
- •Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive
- •Patients who are unable to comply with the trial protocol or who are unable to cooperate with follow-up visits
- •Patients who, in the opinion of the investigator, should not be enrolled in the trial
研究组 & 干预措施
Immuno-cherapy for extensive small cell lung cancer
Experimental
Adebrelimab in combination with famitinib and chemotherapy
干预措施: adebrelimab (Drug)
Immuno-cherapy for extensive small cell lung cancer
Experimental
Adebrelimab in combination with famitinib and chemotherapy
干预措施: famitinib (Drug)
Immuno-cherapy for extensive small cell lung cancer
Experimental
Adebrelimab in combination with famitinib and chemotherapy
干预措施: chemotherapy (Drug)
结局指标
主要结局
6-month progression-free survival
时间窗: up to 6 months
Proportion of disease progression or death from randomization to 6 months of treatment.
次要结局
- 12-month progression-free survival(up to 12 months)
- Objective Response Rate(up to 24 months)
- Disease control rate(up to 24 months)
- Overall Survival(up to 24 months)
- AEs(up to 24 months)
- QoL(up to 24 months)
- Progression-Free-Survival(up to 24 months)
研究者
Yanbin Zhao
MD
Harbin Medical University
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