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NCT07070076 | RECRUITING | Hepatocellular Carcinoma (HCC)

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
Sponsor:

l IQ i Ang

Information provided by (Responsible Party):

l IQ i Ang

Brief Summary:

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

Condition or disease

Hepatocellular Carcinoma (HCC)

Intervention/treatment

Yttrium-90

HAIC

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 286 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2026-08-01
Estimated Primary Completion Date : 2030-08-01
Estimated Study Completion Date : 2031-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
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

Location Details

NCT07070076

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Locations

RECRUITING

China, Guangdong

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China, 510000