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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

NCT07070076 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2025-08-27

No results posted yet for this study

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

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

PROCEDURE

Yttrium-90

Step 1: The MDT team conducts a routine preoperative assessment. Step 2: The interventional team performed tumor vascularity distribution and 99mTc simulation surgery. Step 3: Nuclear Medicine performs SPECT validation and yttrium-90 treatment activity calculation. Step 4: Infusion of yttrium-90 microspheres in the interventional department. Step 5: Nuclear Medicine uses PET/CT or SPECT to determine the distribution of nuclides. If the patient is unwell, he or she can be discharged after 24 hours without special protection. Follow-up examination 1 month after surgery, and then every 2 months, a total of 1 course of treatment. After yttrium-90 treatment, rest for 3-4 months, and arrange hepatectomy after excluding surgical contraindications. The patients in both groups were consulted and discussed by multidisciplinary experts in liver cancer, and elective hepatectomy was arranged after excluding surgical contraindications according to the standardized process.

PROCEDURE

HAIC

After successful percutaneous hepatic artery cannulation, superior mesenteric arteriography and hepatic arteriography are performed, and after the hepatic artery is cannulated to a predetermined position, the patient is returned to the ward with an indwelling catheter. In the ward, a catheter syringe pump is continuously pumped into the following chemotherapy drugs: oxaliplatin 135mg/m2 over 3hrs, leucovorin 400mg/m2 over 1.5hrs, 5-FU 400mg/m2 over 2hrs, 5-FU 2400mg/m2 over 46hrs. After the chemotherapy is completed, the catheter is removed, and the patient can be discharged after 12 hours of compression bandaging to stop the bleeding. Repeat at intervals of 3\~4 weeks, a total of 2 or 4 strokes. For details, see 3.3.1.4 Grouping and Treatment Flow Chart. After the end of HAIC, rest for 3\~4 weeks for re-examination, and arrange liver resection after excluding surgical contraindications.

Sponsors & Collaborators

  • Li Qiang

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2030-08-01
Completion
2031-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070076 on ClinicalTrials.gov