Yttrium-90 internal radiation versus hepatic arterial infusion chemotherapy for potentially resectable intermediate-to-advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This non-randomized, two-arm, multicenter study compares yttrium-90 selective internal radiation therapy (SIRT) against hepatic arterial infusion chemotherapy (HAIC) in adults with potentially resectable intermediate-to-advanced hepatocellular carcinoma. Participants receive either Y-90 SIRT or HAIC and are followed with imaging and clinical visits, including scheduled follow-ups at 1, 3, and 6 months after surgery. The primary outcome is progression-free survival, with safety and conversion-to-resection rates also recorded. Eligible patients are adults aged 18–75 with preserved liver function (Child-Pugh A/B), good performance status, no prior liver cancer treatment, and no extrahepatic metastases.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Jinan University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Qiang Li
• Email: liqiang@jnu.edu.cn
• Phone: 86-19971979632

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.