Prospective Real-World Study of Hepatic Arterial Infusion Chemotherapy (HAIC) With Raltitrexed or 5-Fluorouracil for the Treatment of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,115
- 试验地点
- 2
- 主要终点
- adverse events
研究概览
简要总结
This study is a prospective cohort study aimed at comparing the efficacy and safety of RALOX-HAIC and FOLFOX-HAIC in the treatment of hepatocellular carcinoma. It is planned to enroll 1115 patients with BCLC Stage B or C hepatocellular carcinoma, who will receive FOLFOX-HAIC or RALOX-HAIC treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Presence of clinically significant pleural effusion, ascites, or pericardial effusion that requires repeated treatment (puncture or drainage, etc.);
- •History of immunodeficiency, including positive HIV test, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Severe cardiovascular and cerebrovascular diseases, including but not limited to, myocardial infarction, severe/unstable angina, congestive heart failure (NYHA heart function classification ≥2), clinically significant supraventricular or ventricular arrhythmias requiring drug intervention, aortic aneurysm requiring surgical repair, any arterial thrombosis/embolism events, grade 3 or higher (Common Terminology Criteria for Adverse Events [CTCAE] 5.0) venous thrombosis/embolism events, transient cerebral ischemic attacks, cerebrovascular accidents;
- •Abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation or intra-abdominal abscess within 6 months before the first study drug administration;
- •Severe infection (CTCAE 5.0 > grade 2) occurred within 28 days before the first drug administration, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active infection requiring intravenous anti-infection treatment within 2 weeks before the first drug administration or fever of unknown cause >38.5℃ (subject to the investigator's judgment, fever caused by the tumor can be enrolled);
- •History of another primary malignant tumor, but malignant tumors that have been treated with curative treatment before the first intervention of the study and have no known active disease (more than 5 years) and a low potential for recurrence (such as skin basal cell carcinoma and skin squamous cell carcinoma treated with potential curative treatment) are excluded;
- •History of gastrointestinal bleeding within 6 months before enrollment, or conditions judged by the investigator to have a risk of gastrointestinal bleeding (such as severe esophageal-gastric varices);
- •Other severe physical or mental diseases or laboratory test abnormalities that may increase the risk of participating in the study, affect treatment compliance, or interfere with the study results, and patients judged by the investigator as unsuitable to participate in this study.
排除标准
- •The subject requests to terminate study treatment;
- •Disease progression occurs, and the investigator judges that continuing study treatment has no clinical benefit;
- •Any clinical adverse event, laboratory test abnormality, or other medical condition occurs, making it likely that the subject will no longer benefit from continued medication；
- •Pregnancy occurs in a female subject;
- •There is a significant deviation from the protocol, and the investigator determines that study treatment should be terminated;
- •The subject dies or is lost to follow-up;
- •The study is terminated;
- •Other situations determined by the investigator that require termination of study treatment.
研究组 & 干预措施
FOLFOX-HAIC Cohort
Patients in this group received hepatic arterial infusion chemotherapy, with the following protocol:
Oxaliplatin 85 mg/m^2
Leucovorin calcium 400 mg/m^2
Fluorouracil 400 mg/m^2 on Day 1, 2400 mg/m^2 continuous infusion for 46 hours
Arterial infusion, once every 3 weeks
干预措施: hepatic artery infusion chemotherapy (Drug)
RALOX-HAIC Cohort
Patients in this group received hepatic arterial infusion chemotherapy, with the following protocol:
Oxaliplatin 100 mg/m^2
Raltitrexed 3 mg/m^2
Arterial infusion, once every 3 weeks
干预措施: hepatic artery infusion chemotherapy (Drug)
结局指标
主要结局
adverse events
时间窗: 2 years
Incidence and grading of adverse events (AE) and serious adverse events (SAE).
Time to Progression (TTP)
时间窗: 2 years
Defined as the time from the date of enrollment to the date of any recorded tumor progression.
Progression-Free Survival (PFS)
时间窗: 2 years
Defined as the time from the date of enrollment to the date of any recorded tumor progression or death from any cause.
次要结局
- Objective Response Rate (ORR)(2 years)
- Overall Survival (OS)(2 years)
- Disease Control Rate (DCR)(2 years)