SBRT With DIBH for HCC After TACE and Lipiodol Marking

Study Overview
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Brief Summary
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Stereotactic Body Radiation Therapy (SBRT) for hepatocellular carcinoma (HCC) with radical dose achieved similar results with radiofrequency ablation (RF) and radical surgery, according to previous studies. For tumors near great blood vessels or with a diameter more than 2cm, SBRT performs even better than RF. In current clinical practice of SBRT for small HCC, registration is achieved by planting metal markers near the tumor, which has several disadvantages: 1. the operation is invasive, increase the risk of bleeding in patients with cirrhosis; 2. the operation is of no therapeutic value; 3. metal markers can only be planted outside the tumor to avoid transplantation, which compromises the accuracy of registration via CBCT. This study aims to adopt a new method of registration, transcatheter arterial chemoembolization (TACE) and lipiodol marking, to analyze the recognition and clarity of lipiodol on CBCT images, set-up errors and treatment efficacy. Therefore to provide data to support TACE and lipiodol marking over metal marker planting.

Official Title
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Stereotactic Body Radiation Therapy With Deep Inspiration Breath Hold for Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization and Lipiodol Marking

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Lipiodol marking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically or pathologically confirmed hepatocellular carcinoma. ECOG 0-1. BCLC C Liver-GTV >700ml; intrahepatic metastasis allowed but only one tumor is to be treated with SBRT and others stable for more than 3 months; distant metastasis allowed but stable for more than 6 months. Expected gastric/duodenum/small intestine Dmax 25-35Gy; colon Dmax 28-38Gy. Prescription dose 40Gy/5-10f. DIBH training prior to SBRT to achieve 36 seconds breath hold. Life expectancy > 3 months. Child-Pugh A5, A6 or B7. Liver function: ALT within 1.5 times of upper limit; ALT within 0.5 times of upper limit and AST within 6 times of upper limit, excluding cardiac infarction; ALT within 0.5-1.5 times of upper limit and AST within 1.5 times of upper limit Normal ECG, without severe cardiac dysfunction Kidney function: CRE, BUN within 1.5 times of upper limit. CBC: Hb≥80g/L，ANC≥1.0×109 /L，PLT≥40×109 /L Without hemorrhagic tendency. Voluntarily participate in this trial and sign consent form. Exclusion Criteria: Participants of other clinical trials. History of abdomen radiation therapy or liver transplantation. History of severe cardiovascular, kidney or liver disease. Pregnancy or lactation. Suspected or confirmed of drug or alcohol abuse. History of severe mental or neurological disease, compromising the ability to consent and/or AE diagnosis. Allergic to lipiodol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH which was registrated with lipiodol.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipiodol marking<br>HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH. | Procedure: Lipiodol marking<br>* HCC patients treated with TACE and the tumor marked with lipiodol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recognition of lipiodol marking | Judged by 2 technicians and 1 physician on CBCT images. High recognition is concluded when all three consider it easily registered. Moderate recognition is concluded when two consider it easily registered. Poor recognition is concluded when one or none consider it easily registered. | During the radiotherapy | 
| ORR | Objective response rate | 6 months after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate of treatment model | Including the success rate of lipiodol deposition at 1 months after TACE and completion of SBRT | 1 months after TACE | 
| LCR | Local control rate | 12 months and 24 months after radiotherapy | 
| PFS | Progress free survival | 12 months and 24 months after radiotherapy | 
| Frequency of AE | Frequency of treatment associated adverse events | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, TACE, SBRT, DIBH