RecruitingPhase 2NCT06205472

Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.

Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

100 participants

Start Date

Jan 26, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Radiotherapy Narrow Margin

Summary

This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(\<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether delivering radiation therapy to the liver after surgical removal of a liver cancer (hepatocellular carcinoma, HCC) with very close margins (less than 1 cm of clear tissue) reduces the risk of the cancer coming back. **You may be eligible if...** - You have had liver cancer surgically removed, but the margins were very narrow (less than 1 cm) - You are an adult over 18 in good general health (ECOG 0–1) - Your liver is functioning well (Child-Pugh A5 or A6) - You have no evidence of spread to other organs - Your blood counts, liver, and kidney function meet minimum levels - Surgery was within the last 3 months **You may NOT be eligible if...** - You have had another cancer (other than minor skin cancers) - You have had prior radiation to the abdomen - You have had a liver transplant - You have serious heart disease or kidney failure - You have significant fluid buildup in the abdomen (ascites with symptoms) 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

RADIATIONAdjuvant SIB radiotherapy

Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions,mainly depending on the dose constraints of OARs.