NCT05609695尚未招募不适用
Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeted Drugs / Locoregional Therapy in the Treatment of Hepatocellular Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
Non-intervention observation to evaluate the safety and efficacy of immune checkpoint inhibitors alone or combined with molecular targeted drugs / local interventional therapy in patients with advanced liver cancer, and to provide the best choice for the treatment of patients with advanced liver cancer in different stages.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent must be obtained prior to any screening procedures.
- •Cytohistological confirmation is required for diagnosis of HCC.
- •Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer [BCLC] staging classification) hepatocellular carcinoma which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection, percutaneous hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy.
- •At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.
- •Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
- •Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
- •astern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤
- •Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial.
- •Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to procedure:
- •Hemoglobin > 100g/L Absolute neutrophil count >3.0 ×109/L Neutrophil count > 1.5 ×109/L Platelet count ≥ 50.0 ×109/L Total bilirubin < 51 μmol/L Alanine transaminase (ALT) and aminotransferase (AST) < 5 x upper limit of normal Albumin > 28 g/L Prothrombin time (PT)-international normalized ratio (INR) < 2.3, or PT < 6 seconds above control Serum creatinine < 110 μmol/L
- •Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
排除标准
- •Received any prior systemic chemotherapy or molecular-targeted therapy for HCC such as sorafenib, lenvatinib.
- •Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity > grade
- •Any contraindications for Immune checkpoint inhibitor procedure
- •Renal failure / insufficiency requiring hemo-or peritoneal dialysis.
- •Known severe atheromatosis.
- •Known uncontrolled blood hypertension (> 160/100 mm/Hg).
- •Patients with any other malignancies within the last 3 years before study start.
- •History of HCC tumor rupture.
- •Patients with severe encephalopathy. Patients with known active bleeding (e.g. from GI ulcers, esophageal varices) within 2 months prior to baseline/screening visit or with history or evidence of inherited bleeding diathesis or coagulopathy.
- •History of cardiac disease.
- •Any other condition that would, in the Investigator's judgment, contraindicate patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable or unwilling to swallow medication, social/ psychological issues, etc.
- •Patients who have received any other investigational agents within a period of time that is less than the cycle length used for that treatment or equal to 4 weeks (whichever is shorter) prior to starting study drug and recovered from any side effects to grade 1 or less.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
研究组 & 干预措施
Immunotherapy group
Treatment based on immunotherapy.
干预措施: Immune checkpoint inhibitor (Drug)
结局指标
主要结局
Overall Survival
时间窗: 3-years Followed up
Absence of death of any cause
次要结局
- Tumor Response(3-years Followed up)
- Progress Free Survival(3-years Followed up)
研究者
Ming Zhao
Chief physician
Sun Yat-sen University
研究点 (1)
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