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

Official title

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

Overview

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

Interventions

• Procedure 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
• Procedure 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

Primary outcome measures

• Progression-Free Survival, PFS [Time frame: 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]

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Jinan University — Guangzhou

Identifiers

NCT: NCT07070076 · FirstJinanUHospital

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗