NCT07070076招募中不适用
A Two-Arm, Multicenter, Non-Randomized Controlled Study on the Efficacy of Yttrium-90 (SIRT) Therapy and Hepatic Arterial Infusion Chemotherapy (HAIC) for Potentially Resectable Intermediate and Advanced Hepatocellular Carcinoma
Li Qiang1 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2026年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Progression-Free Survival, PFS
研究概览
简要总结
The objective of this clinical trial is to compare the effects of yttrium-90 (SIRT) treatment and hepatic arterial perfusion chemotherapy (HAIC) on progression-free survival (PFS) in patients with potentially resectable HCC in the HCC population. The main questions it aims to answer are:
- Whether yttrium-90 (SIRT) therapy is more effective than hepatic arterial infusion chemotherapy (HAIC) in treating patients with potentially resectable liver cancer
- Whether yttrium-90 (SIRT) therapy is safer than hepatic arterial perfusion chemotherapy (HAIC) in patients with potentially resectable liver cancer The researchers compared yttrium-90 (SIRT) treatment to hepatic arterial perfusion chemotherapy (HAIC) to see if yttrium-90 (SIRT) was more effective in treating potentially resectable liver cancer.
Participants will:
- Patients will receive yttrium-90 (SIRT) therapy or 1 of them hepatic arterial perfusion chemotherapy (HAIC).
- Follow-up at 1, 3, and 6 months after surgery
- Keep a record of their symptoms and test results
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
- •Age ≥ 18 years and ≤ 75 years.
- •Good general condition, with an ECOG Performance Status (PS) of 0-
- •Classified as China Liver Cancer Staging (CNLC) stage Ib (PS 0-2, Child-Pugh class A/B liver function, single tumor >5 cm in diameter, without radiologically visible vascular tumor thrombus and extrahepatic metastasis), IIa (PS 0-2, Child-Pugh class A/B liver function, 2-3 tumors with the largest diameter >3 cm, without radiologically visible vascular tumor thrombus and extrahepatic metastasis), IIb (PS 0-2, Child-Pugh class A/B liver function, ≥4 tumors regardless of diameter, without radiologically visible vascular tumor thrombus and extrahepatic metastasis), or IIIa (PS 0-2, Child-Pugh class A/B liver function, any tumor status with radiologically visible vascular tumor thrombus but without extrahepatic metastasis).
- •No prior treatment for liver cancer.
- •Absence of distant metastasis, with the tumor anticipated to be completely resectable.
- •Patient provides written informed consent after being fully informed about the study.
排除标准
- •Presence of severe impairment of heart, brain, lung, kidney, or other major organ function, severe concurrent infection, or other serious comorbid conditions (> Grade 2 adverse events per CTCAE Version 4.03), rendering the patient unable to tolerate the treatment.
- •History of other malignancies.
- •History of allergy to related drugs.
- •History of organ transplantation.
- •Prior treatment for the tumor (including interferon).
- •Concurrent HIV infection.
- •History of drug or substance abuse.
- •Occurrence of gastrointestinal bleeding or cardiovascular/cerebrovascular events within approximately 30 days prior to treatment.
- •Pregnant or lactating women, or women of childbearing potential unwilling to use contraception.
- •Concurrent psychiatric disorders that prevent the patient from providing informed consent or interfere with receiving treatment.
- •Any other factors deemed by the investigator as likely to affect patient enrollment or the evaluation of results.
结局指标
主要结局
Progression-Free Survival, PFS
时间窗: The time interval between the start of treatment and the time when the tumor has progressed (e.g., increase in size, metastasize) or died due to any cause, an average of 2 year
It is a key indicator to evaluate the "ability to delay disease progression" of cancer therapy, especially for the analysis of interim efficacy of long-survival or advanced cancers.
次要结局
- Overall Survival Time (OS)(The patient was treated for the first time until death, an average of 2 year)
- Objective Response Rate, ORR(From the first time the patient is treated to the patient's follow-up for disease progression, an average of 2 year)
- Disease Control Rate, DCR(The patient was treated for the first time until death, an average of 2 year)
- Safety of treatment (incidence of treatment-related adverse events assessed by CTCAE Version 4.03)(From the time of first treatment to the patient's death, an average of 2 year)
- Surgical resection rate(The time interval from the start of treatment to death due to any cause, an average of 2 year)
研究者
Li Qiang
Chief Physician of Hepatobiliary Surgery
First Affiliated Hospital of Jinan University
研究点 (1)
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