Yttrium-90 internal radiation versus hepatic arterial infusion chemotherapy for potentially resectable intermediate-to-advanced liver cancer
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
This study will try whether yttrium-90 internal radiation (SIRT) or hepatic arterial infusion chemotherapy (HAIC) works better for adults with potentially resectable intermediate-to-advanced hepatocellular carcinoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Jinan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07070076 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with potentially resectable HCC, good performance status (ECOG 0–1), Child-Pugh A/B liver function, no prior liver cancer treatments, and no extrahepatic metastases.
Not a fit: Patients with extrahepatic metastases, decompensated liver disease (Child-Pugh C), poor performance status, or prior liver-directed therapies are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could identify which locoregional therapy better delays tumor progression and increases the chance of curative surgery for patients with potentially resectable HCC.
How similar studies have performed: Previous studies have shown both Y-90 SIRT and HAIC can provide local tumor control and sometimes downstage tumors to resection, but high-quality head-to-head randomized comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.