A Two-Arm, Multicenter, Non-Randomized Controlled Study on the Efficacy of Yttrium-90 (Selective Internal Radiation Therapy) Therapy and Hepatic Arterial Infusion Chemotherapy (Hepatic Artery Infusion Chemotherapy) for Potentially Resectable Intermediate and Advanced Hepatocellular Carcinoma

Официальное название

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

Обзор

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

Вмешательства

• Процедура Yttrium-90
  Step 1: The MDT team conducts a routine preoperative assessment. Step 2: The interventional team performed tumor vascularity distribution and 99mTc simulation surgery. Step 3: Nuclear Medicine performs SPECT validation and yttrium-90 treatment activity calculation. Step 4: Infusion of yttrium-90 microspheres in the interventional department. Step 5: Nuclear Medicine uses PET/CT or SPECT to determine the distribution of nuclides. If the patient is unwell, he or she can be discharged after 24 hour
• Процедура HAIC
  After successful percutaneous hepatic artery cannulation, superior mesenteric arteriography and hepatic arteriography are performed, and after the hepatic artery is cannulated to a predetermined position, the patient is returned to the ward with an indwelling catheter. In the ward, a catheter syringe pump is continuously pumped into the following chemotherapy drugs: oxaliplatin 135mg/m2 over 3hrs, leucovorin 400mg/m2 over 1.5hrs, 5-FU 400mg/m2 over 2hrs, 5-FU 2400mg/m2 over 46hrs. After the chem

Первичные конечные точки

• Progression-Free Survival, PFS [Срок оценки: 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]

Вторичные конечные точки (5)

• Overall Survival Time (OS) [Срок оценки: The patient was treated for the first time until death, an average of 2 year]
• Objective Response Rate, ORR [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: From the time of first treatment to the patient's death, an average of 2 year]
• Surgical resection rate [Срок оценки: The time interval from the start of treatment to death due to any cause, an average of 2 year]

Критерии участия

Критерии включения

• Age ≥ 18 years and ≤ 75 years.
• Good general condition, with an ECOG Performance Status (PS) of 0-1.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Jinan University — Гуанчжоу

Идентификаторы

NCT: NCT07070076 · FirstJinanUHospital

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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