Yttrium-90 treatment for large liver cancer

Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial

This study is testing whether a special radiation treatment using yttrium-90 can help people with large liver cancer that can’t be surgically removed feel better and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06707233 on ClinicalTrials.gov

What this trial studies

This phase II clinical study evaluates the efficacy and safety of selective internal radiation therapy (SIRT) using yttrium-90 in patients with unresectable hepatocellular carcinoma (HCC) larger than 7 cm. Participants will receive SIRT after thorough evaluation, and the primary endpoint is the objective response rate (ORR) assessed by modified RECIST criteria. Secondary endpoints include overall survival, progression-free survival, and safety assessments. The study aims to provide insights into the effectiveness of this treatment approach for a challenging patient population.

Who should consider this trial

Good fit: Ideal candidates include patients with pathologically confirmed or clinically diagnosed unresectable HCC larger than 7 cm and adequate organ function.

Not a fit: Patients with macrovascular invasion, extrahepatic metastasis, or decompensated liver function are unlikely to benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with large, unresectable liver tumors.

How similar studies have performed: Previous studies have shown promising results with SIRT in similar patient populations, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Pathologically confirmed or clinically diagnosed HCC
* Unresectable HCC as assessed by a team of surgeons
* The largest tumor size \> 7 cm
* Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
* At least one measurable intrahepatic target lesion
* Appropriate for SIRT treatment after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
* Child-Pugh score ≤ 7
* ECOG PS ≤ 1
* Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
* life expectancy of at least 6 months

Exclusion Criteria:

* Macrovascular invasion or extrahepatic metastasis
* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy
* Organ (heart and kidneys) dysfunction
* History of other malignancies
* Uncontrollable infection
* History of organ or cells transplantation
* History of HIV
* Pregnant or lactating patients

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Mingyue Cai, Dr.

Conditions: Hepatocellular Carcinoma Non-Resectable, Hepatocellular Carcinoma, yttrium-90, selective internal radiation therapy