NCT07300488进行中（未招募）2 期
Randomized, Controlled, Open-Label, Multicenter Phase Ⅱ/Ⅲ Seamless Adaptive Design Registration Clinical Trial of Pracytarabine Versus Regorafenib for Advanced Hepatocellular Carcinoma After Failure of Targeted Drugs and Immune Checkpoint Inhibitors or Dual Immune Checkpoint Inhibitors Therapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 9-month Overall Survival (OS) rate
研究概览
简要总结
This is a Phase 2/3 study evaluating the efficacy and safety of Pracytarabine versus regorafenib in patients with advanced hepatocellular carcinoma (HCC) who have experienced treatment failure with standard systemic therapies involving targeted drugs and immune checkpoint inhibitors, or dual immune checkpoint inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Care Provider)
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
- •Aged 18-75 years, regardless of gender.
- •Diagnosed with HCC either by histopathological and/or cytological examination meeting pathological diagnostic criteria, or in line with the clinical diagnostic criteria of the aforementioned guidelines.
- •Unresectable or metastatic HCC, and have experienced treatment failure with targeted drugs and immune checkpoint inhibitors.
- •Child-Pugh liver function score: Class A/B (≤7 points).
- •Expected survival time ≥ 3 months.
- •ECOG performance status 0 or
- •Barcelona Clinic Liver Cancer (BCLC) stage B or C.
- •No severe involvement of the portal vein, and no invasion of the hepatic vein, superior vena cava, or inferior vena cava.
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- •Previous history of liver or other organ transplantation.
- •Has participated in another clinical study within 4 weeks prior to the first dose.
- •Has a known history of, or any evidence of CNS metastases.
- •Clinically symptomatic or recurrently drained pleural effusion, pericardial effusion, or ascites.
- •History of bleeding event due to esophageal and/or gastric varices within 3 months prior to the first dose of study treatment.
研究组 & 干预措施
Pracytarabine
Experimental
Treatment with 1200 mg/m²/d Pracytarabine
干预措施: Pracytarabine (Drug)
regorafenib
Active Comparator
Treatment with regorafenib 160 mg once daily
干预措施: regorafenib (Drug)
结局指标
主要结局
9-month Overall Survival (OS) rate
时间窗: Up to 12 months
9-month Overall Survival (OS) rate：The proportion of the total number of subjects who survived for 9 months from randomization.
次要结局
- Progression-free survival (PFS) assessed by investigator per RECIST v1.1(Up to 12 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Trial assessing a regorafenib-irinotecan combination (REGIRI) versus regorafenib alone in metastatic colorectal cancer patients after failure of standard therapies.2024-512555-21-00Institut Regional Du Cancer De Montpellier78
招募中
3 期
Efficacy and Safety of Deucravacitinib Compared with Placebo in
Participants with Active Psoriatic Arthritis (PsA) who are Naïve to Biologic
Disease-modifying Anti-rheumatic Drugs2023-506256-25-00Bristol Myers Squibb International Corporation326
招募中
1 期
Phase Ib study of the combination of regorafenib with conventional chemotherapy for the treatment of newly diagnosed patients with multimetastatic Ewing sarcoma - REGO-INTER-EWING12023-503322-39-00Institut Gustave Roussy26
尚未招募
2 期
Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority TrialNCT07261709Sun Yat-sen University236
招募中
3 期
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or BHemophiliaNCT07285460Sanofi85