NCT06530784尚未招募2 期
Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma After Progression of PD-1/L1 Antibody Treatment: a Pilot Clinical Study
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年7月31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
- 36
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
To explore the safety and efficacy of cryoablation combined with PD-1 antibody and bevacizumab for patients with hepatocellular carcinoma resistance to PD-1/L1 antibody.
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 between 18 and 80 years old, and expected survival is longer than 3 months
- •Clinically or pathologically diagnosed as primary hepatocellular carcinoma
- •Disease progression assessed according to mRECIST criteria after PD-1/L1 antibody treatment
- •Child-Pugh score of liver function A/B (< 7)
- •At least one lesion is suitable for mRECIST assessment
- •Strength score (ECOG): 0-1
- •The patient and/or family members agree to join the clinical trial and sign the informed consent form
排除标准
- •Patients whose tumor lesions are not suitable for ablation as assessed by the surgeon
- •Tumor burden greater than ≥70%, or tumor is not suitable for mRECIST standard evaluation
- •Patients with chronic viral hepatitis (hepatitis B, hepatitis C) have a viral load greater than 10^4 before receiving treatment or do not continue to take antiviral drugs regularly
- •Pregnant patients
- •Combined with other malignant tumors, or have a history of other malignant tumors within 3 years
- •Active autoimmune disease, confirmed immunodeficiency, history of systemic steroid medication
- •Severe renal dysfunction: creatinine (Cr) > 2 mg/dL or creatinine clearance (CCr) <30 mL/min, severe heart, lung, brain and other important organ diseases
- •History of gastrointestinal bleeding within 3 months
- •Unable to cooperate with ablation surgery
- •Severe gastroesophageal varices
研究组 & 干预措施
treatment group
Experimental
Cryoablation combined with PD-1 antibody and bevacizumab
干预措施: Cryoablation (Procedure)
treatment group
Experimental
Cryoablation combined with PD-1 antibody and bevacizumab
干预措施: PD-1 antibody and bevacizumab (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Up to 2 years
mRECIST is used as the evaluation criterion for CT/MRI imaging at each follow-up visit.
次要结局
- Time to progress(Up to 2 years)
- Overall survival(Up to 2 years)
- Objective Response Rate(Up to 2 years)
- Adverse events(Up to 2 years)
研究者
研究点 (1)
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