NCT06365034招募中不适用
A Single-center, Retrospective Study on the Efficacy and Safety of Conversion Therapy for Patients With Initially Unresectable Hepatocellular Carcinoma
Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Pathologic response rate
研究概览
简要总结
To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC).
详细描述
To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC). Exon sequencing, 16SrRNA sequencing and immunohistochemistry were used to verify the protein expression, revealing the mechanism of tumor occurrence and development from the genome level, and providing reference for immunotherapy, targeted drug use and curative effect evaluation of tumors.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •≥ 18 years old, gender is not limited;
- •Patients with radiographically or pathologically confirmed, unresectable advanced hepatocellular carcinoma;
- •At least one measurable lesion according to the mRECIST criteria as the target lesion;
- •No prior immunotherapy, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 antibodies;
- •Patients with an ECOG score of 0-2 were included according to the activity status score scale developed by the Eastern Cooperative Oncology Group (ECOG) in the United States;
- •Child-Pugh liver function is graded as A or B.
排除标准
- •Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases;
- •Have other malignancies;
- •Presence of any active autoimmune disease or history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or other patients who are considered by the investigator to have an impact on study treatment;
- •Long-term heavy use of corticosteroids or other immunomodulators;
- •Serious illness in combination with other systems;
- •Received a live or attenuated vaccine within 30 days prior to the first dose, or plans to receive a live or attenuated vaccine during the study, excluding the new crown vaccine;
- •Known human immunodeficiency virus (HIV) infection;
- •Have participated in other therapeutic clinical studies;
- •Incomplete clinical data.
结局指标
主要结局
Pathologic response rate
时间窗: 2 years
Proportion of patients whose tumors have shrunk to a prespecified value and are able to maintain the minimum time limit
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
A Model for Predicting the Efficacy of Conversion Therapy for Patients With Colorectal Cancer Liver Metastases by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNAColorectal Cancer With Liver MetastasesNCT03679039Fudan University100
已完成
2 期
Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies: Follow-up StudyHepatocellular CarcinomaNCT02745483Seoul National University Hospital153
已完成
不适用
Treatment Patterns and Treatment Outcomes for AcromegalyAcromegalyNCT03043586Columbia University520
尚未招募
不适用
Study on the Efficacy and Safety of Transarterial Chemoembolization Combined with Targeted Immunotherapy in Patients with Unresectable Hepatocellular CarcinomaUnresectable Liver CancerNCT06715072Yao Xie70
已完成
不适用
Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)Bowel Disorders FunctionalUrinary Incontinence, UrgeFecal IncontinenceUrinary IncontinenceUrge IncontinenceNocturiaUrinary Frequency More Than Once at NightIncontinence, Nighttime UrinaryNCT05368246InnoCon Medical80