A Real World Study of Camrelizumab Combined With Apatinib Mesylate in Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- AE
研究概览
简要总结
The purpose of this study is to observe the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors
详细描述
According to current studies, the combination of camrelizide and apatinib mesylate has significant efficacy and controllable toxicity in the treatment of solid tumors.
This study adopted camrelizumab combined with apatinib mesylate in the treatment of solid tumors, aiming to further explore the safety of camrelizumab combined with apatinib mesylate in the treatment of solid tumors and provide more research data for the treatment of solid tumors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥18 years old, male or female;
- •ECOG score is 0~2;
- •Patients with solid tumors confirmed by pathology or histology;
- •At least one measurable lesion (according to RECIST V 1.1);
- •For patients who have failed first-line or second-line treatment or who cannot tolerate standard treatment regimens for solid tumors.
- •Estimated survival ≥3 months;
- •Patients who have used immunosuppressants or antiangiogenic drugs in the past are not excluded;
- •For women who have not undergone menopause or surgical sterilization, agree to abstain from sex or use an effective contraceptive method during treatment and for at least 7 months after the last dose given in study treatment;
- •Researchers think they can benefit;
- •Voluntarily participate in the study and sign the informed consent;
排除标准
- •Pregnant or lactating women;
- •Except patients with contraindications to camrelizumab and/or apatinib mesylate, that is, those allergic to camrelizumab and its excipients; Allergic to apatinib mesylate should be prohibited; It should be contraindication for patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension beyond drug control within 30 days after major surgery, class III-IV cardiac insufficiency (NYHA standard), and severe hepatic or renal insufficiency (Class 4).
- •Those deemed unsuitable for inclusion by doctors;
- •The researchers determined there was a high risk that the tumor would invade important blood vessels and cause fatal hemorrhages during the follow-up study
研究组 & 干预措施
Camrelizumab combined with apatinib mesylate
Camrelizumab 200 mg, IVGTT D1, apatinib mesylate, once daily. The specific prescription is determined by the investigator. Continued use until disease progression, unacceptable toxicity, or withdrawal for other reasons.
干预措施: Camrelizumab combined with apatinib mesylate (Drug)
结局指标
主要结局
AE
时间窗: up to 2 years
any adverse medical event that occurs after a subject or clinical study receives a drug or treatment regimen
次要结局
- Objective response rate(up to 2 years)
- Disease control rate(up to 2 years)
- Overall survival(up to 2 years)
研究者
LiNing
Associate Chief Physician
Henan Cancer Hospital