NCT06061445招募中不适用
A Study to Evaluate the Effects of Radiotherapy Combined With Tyrosine Kinase Inhibitor (TKI) and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma With Portal Vein Tumor Thrombus(PVTT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
The purpose of this clinical research study is to investigate the efficacy and safety of Radiotherapy Combined with TKI and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma with Portal Vein Tumor Thrombus(PVTT).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary hepatocellular carcinoma who strictly meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 edition) or who have been confirmed by histopathology or human cytology, There was at least one measurable lesion (spiral CT scan length ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard);
- •Patients with advanced primary hepatocellular carcinoma who have not received systematic treatment and cannot be surgically resectable;
- •CNLC was divided into stage IIIA, VP1-3 type;
- •Child-Pugh classification of liver function is grade A (5-6 points);
- •ECOG PS score 0-1;
- •Expected survival ≥12 weeks;
- •Patients with active hepatitis B virus (HBV) infection must be willing to receive antiviral treatment throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral therapy according to standard local treatment guidelines and have liver function within CTCAE level 1 elevation;
- •The major organs function normally and meet the following criteria :
- •The blood routine examination criteria should meet :(no blood transfusion within 14 days)
- •Hemoglobin (HB)≥90g/L,
- •White blood cell count (WBC)≥3×109/L,
- •Absolute neutrophil count (ANC)≥1.5×109/L,
- •platelets (PLT)≥75×109/L;
- •Biochemical examination should meet the following criteria:
- •Bilirubin (BIL)< 1.5 times the upper limit of normal value (ULN);
- •Alanine aminotransferase (ALT) and aspartate aminotransferase AST<5ULN;
- •Serum creatinine (Cr)≤1.5ULN
- •Women of childbearing age must have a negative pregnancy test (serum) or urine HCG test within 7 days prior to admission and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last dose of the test drug; For males, they should be surgically sterilized or agree to use appropriate methods to avoid pregnancy during the trial and for 8 weeks after the last dose of the trial drug;
- •The subjects voluntarily joined the study, had good compliance, and cooperated with follow-up.
排除标准
- •Pregnant or lactating women;
- •Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ);
- •Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness;
- •Patients with a history of epigastric radiotherapy;
- •Patients who fail to follow dose limits for vital organs in the radiotherapy program, including patients with normal liver tissue less than 700 ml in the radiotherapy program;
- •Patients who have participated in other clinical trials in the past three months;
- •Previously received targeted therapy or other PD-1/PD-L1 inhibitor therapy;
- •Received major surgery or chemotherapy, radiation therapy or other focal systemic therapy within 1 month before enrollment;
- •Immunosuppressive agents or systemic hormone therapy (dose >10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression;
- •Liver function was classified as Child-Pugh C, which could not be improved by liver protection treatment.
- •Esophageal (fundus) varices rupture and bleeding within 1 month before treatment.
- •Uncorrectable coagulation dysfunction and severe blood abnormalities, with a tendency to severe bleeding. Platelet count <50×109/L and severe coagulation dysfunction can not withstand surgery (anticoagulant therapy and/or anticoagulant drug use should be stopped more than 1 week before radiotherapy);
- •Refractory ascites, bad fluid;
- •Active infection, especially inflammation of the biliary system;
- •Severe liver, kidney, heart, lung, brain and other major organ failure;
- •People who have been allergic to any component of PD-1 monoclonal antibody or other similar experimental drugs;
- •Have high blood pressure and can not be reduced to normal by antihypertensive medication
结局指标
主要结局
OS
时间窗: the date of first administration to the subject's death from various causes
Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.
ORR
时间窗: The best efficacy recorded between the date of first administration and the date of objective recording of progress according to mRECIST 1.1 criteria or the date of initiation of subsequent antitumor therapy, whichever occurs first
Assessed according to the modified Response Evaluation Criteria in Solid Tumors Version 1.1, undergoing enhanced CT/MRI.
次要结局
未报告次要终点
研究者
研究点 (1)
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