RecruitingNot ApplicableNCT05596630

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

40 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a focused radiation treatment called Stereotactic Body Radiation Therapy (SBRT) for small liver tumors that have come back after previous liver cancer treatment. Researchers want to see if this targeted radiation approach is safe and helps patients live longer. **You may be eligible if...** - You have been diagnosed with liver cancer (HCC) without spread to lymph nodes or distant organs - You had previous surgery or radiofrequency ablation, and the cancer has returned but was free for at least 6 months after treatment - Your cancer is early stage: either a single tumor under 5 cm, or up to 3 tumors all under 3 cm - Your liver function is adequate (Child-Pugh A or B) **You may NOT be eligible if...** - Your cancer has spread outside the liver - You have more than 3 tumors, or tumors larger than the criteria above - You have poor liver function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic 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.


Locations(1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT05596630


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