SBRT With DIBH for HCC After TACE and Lipiodol Marking

  • STATUS
    Recruiting
  • days left to enroll
    89
  • participants needed
    30
  • sponsor
    Chinese Academy of Medical Sciences
Updated on 2 September 2021
metastasis
TACE

Summary

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.

Details
Condition Adenocarcinoma, Liver Cancer, HEPATIC NEOPLASM, Malignant Adenoma, liver cell carcinoma, HEPATOCELLULAR CARCINOMA
Treatment Lipiodol marking
Clinical Study IdentifierNCT05021250
SponsorChinese Academy of Medical Sciences
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

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: Hb80g/LANC1.0109 /LPLT40109 /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
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