Clinical Study of Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of Extensive Stage Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety: Dose-limiting toxicities
研究概览
简要总结
The efficacy of PD-1/PD-L1 combined with chemotherapy in the treatment of extensive small-cell lung cancer is still unsatisfactory. PD-1/PD-L1 combined with chemotherapy and anti-angiogenic drugs may achieve better efficacy.
详细描述
Camrelizumab is a humanized PD-1 monoclonal antibody. Camrelizumab combined with the antiangiogenic drug apatinib has achieved good efficacy in extensive small-cell lung cancer. Median OS is 8.4 months. In our study, subjects with extensive stage small cell lung cancers receive 2 cycles of chemotherapy followed by carrizumab combined with apatinib and chemotherapy. we hope to achieve a better outcome.
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
- •Extensive stage small cell lung cancer proved by pathology.
- •Extensive small cell lung cancer does not receive systematic treatment.
- •limited SCLC patients have received radiotherapy and chemotherapy for more than 6 months.
- •patients have measurable lesions according to RECIST version 1.
- •Male or female who is 18 to 75 years old.
- •ECOG PS 0 or
- •Life expectancy is more than12 weeks.
- •Appropriate organ system function.
- •hyroid-stimulating hormone is ULN or less (If T3 and T4 is normal, he still meets the Inclusion Criteria even the abnormal TSH. )
- •Take proper contraceptive measures.
- •Subjects voluntarily participate in this study and sign the informed consent.
排除标准
- •Previous treatment with apatinib, anti-programmed cell death (PD-1), anti-PD-1, or other PD-1/ PD-L1 immunotherapy.
- •Cancer meningitis.
- •patients had been diagnosed and/or treated for other malignancies within 5 years prior to enrollment, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- •There are many factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc..
- •Uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage.
- •Patients with spinal cord compression who were not cured or relieved by surgery and/or radiotherapy, or who were diagnosed with spinal cord compression after treatment and without clinical evidence of stable disease ≥1 week before enrollment;
- •Patients with hypertension who cannot be well controlled by oral antihypertensive therapy, suffer from myocardial ischemia or myocardial infarction of grade I or above, arrhythmias of grade I or above , or cardiac insufficiency;
- •Subjects had signs of bleeding, hemoptysis, or a history of unhealed wounds, ulcers, fractures within 2 months prior to initial administration.
- •The adverse events caused by previous treatment did not completely recover.
- •Patients with major surgery or obvious traumatic injury within 28 days before enrollment;
- •Occurred arterial or venous thromboembolism events within 6 months.
- •People with a history of drug abuse or mental disorders.
- •Suffering from a serious and/or uncontrollable disease;
- •Vaccination or attenuated vaccine received within 4 weeks.
- •Severe allergies that require treatment with other monoclonal antibody drugs;
- •Active autoimmune disease requiring systemic treatment within 2 years prior to the first administration;
- •Immunosuppressive therapy with systemic or absorbable local hormones and continued for 2 weeks after the first dose;
- •Participate in other anticancer drug clinical trials within 4 weeks;
- •In the investigator's judgment, there are other factors that may have led to the termination of the study.
研究组 & 干预措施
Cohort one
Extensive SCLC patients who are Peripheral type or tumor vascular invasion grade one or less.
干预措施: Camrelizumab; apatinib; carboplatin; etoposide (Drug)
Cohort two
Extensive SCLC patients who are central type or tumor vascular invasion grade two to three.
干预措施: Camrelizumab; apatinib; carboplatin; etoposide (Drug)
结局指标
主要结局
Safety: Dose-limiting toxicities
时间窗: Followed up every 3 weeks.
Any level 4 or greater hematologic toxicity and any level 3 or greater non-hematologic toxicity (accroding to CTC AE 5.0)
次要结局
- 12 months OS(Followed up by telephone every 2 months)
- PFS(Imageological diagnosis every 6 weeks)
研究者
Zhou Chengzhi
Professor
Guangzhou Institute of Respiratory Disease