NCT05596630

Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent HCC

A Single-center, Unblinded, Single-arm, Prospective Trial of Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent Hepatocellular Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Primary liver cancer is one of the common malignant tumors in China, of which hepatocellular carcinoma (HCC) accounts for 85%-90%. It is worth noting that the recurrence rate of liver cancer is greater than 10% at 1 year after surgery, while the recurrence rate in 5 years reaches 70-80%. Stereotactic body radiation therapy (SBRT) refers to a kind of radiotherapy technology to achieve a steep dose gradient and achieve high-precision position and high-dose fractionated irradiation. The rapid dose drop-down enables SBRT to maximize the protection of normal tissues around the tumor, and it often requires only 1-5 times of high-dose fractionated irradiation to complete the course of treatment.SBRT may play an important role in the treatment of small intrahepatic recurrence HCC, but there is still a lack of evidence of high-level prospective studies. We intend to conduct a single-center, prospective, clinical study to further elaborate the efficacy and safety of SBRT in the treatment of small intrahepatic recurrent HCC.

Detailed description

Patients with recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chosen for this study. A total of 40 patients will be scheduled to be enrolled. The patients enrolled will be treated with SBRT with no adjuvant therapy, and they will be followed up according to the plan.

Conditions

• Carcinoma; Hepatocellular

Interventions

Type	Name	Description
RADIATION	Stereotactic body radiation therapy	Stereotactic body radiotherapy for small intrahepatic recurrent HCC. Radiation dose: Greater than or equal to 40Gy/4-5F, complete treatment within 1 week.

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2022-10-27
• Last updated: 2025-02-10

Locations

1 site across 1 country: China