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
Launched by LI QIANG · Jul 7, 2025
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different treatments for liver cancer called hepatocellular carcinoma (HCC) that might still be removable by surgery. The researchers want to find out if a treatment called yttrium-90 selective internal radiation therapy (SIRT), which delivers targeted radiation directly to the tumor, works better and is safer than another treatment called hepatic arterial infusion chemotherapy (HAIC), where chemotherapy drugs are delivered directly to the liver. The main goal is to see which treatment helps patients live longer without the cancer getting worse.
People who may join this study are adults between 18 and 75 years old, with liver cancer that meets certain conditions making surgery possible, and who are generally in good health. Participants will receive either the radiation treatment or the chemotherapy through the liver’s blood vessels. After treatment and surgery, they will have follow-up visits at 1, 3, and 6 months to check on their health, symptoms, and test results. If you or a loved one is considering this trial, it’s important to know that the study is currently recruiting patients and requires a commitment to regular check-ups and monitoring during the treatment process.
Gender
ALL
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.
About Li Qiang
Li Qiang is a clinical trial sponsor specializing in advancing medical research through the coordination and support of innovative clinical studies. Committed to improving patient outcomes, Li Qiang oversees the design, implementation, and management of trials that adhere to rigorous ethical and regulatory standards, fostering collaboration among healthcare professionals and research institutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Guangzhou, Guangdong, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported