Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, TACE, SBRT, DIBH
Brief 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.
Interventions
PROCEDURELipiodol marking
HCC patients treated with TACE and the tumor marked with lipiodol.
Sponsors
The First Hospital of Jilin University
Tianjin Medical University Cancer Institute and Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH which was registrated with lipiodol.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Clinically or pathologically confirmed hepatocellular carcinoma. 2. ECOG 0-1. 3. BCLC C 4. 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. 5. Expected gastric/duodenum/small intestine Dmax 25-35Gy; colon Dmax 28-38Gy. Prescription dose 40Gy/5-10f. 6. DIBH training prior to SBRT to achieve 36 seconds breath hold. 7. Life expectancy \> 3 months. 8. Child-Pugh A5, A6 or B7. 9. 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 10. Normal ECG, without severe cardiac dysfunction 11. Kidney function: CRE, BUN within 1.5 times of upper limit. 12. CBC: Hb≥80g/L，ANC≥1.0×109 /L，PLT≥40×109 /L 13. Without hemorrhagic tendency. 14. Voluntarily participate in this trial and sign consent form.
Exclusion criteria
1. Participants of other clinical trials. 2. History of abdomen radiation therapy or liver transplantation. 3. History of severe cardiovascular, kidney or liver disease. 4. Pregnancy or lactation. 5. Suspected or confirmed of drug or alcohol abuse. 6. History of severe mental or neurological disease, compromising the ability to consent and/or AE diagnosis. 7. Allergic to lipiodol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recognition of lipiodol marking | During the radiotherapy | 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. |
| ORR | 6 months after radiotherapy | Objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion rate of treatment model | 1 months after TACE | Including the success rate of lipiodol deposition at 1 months after TACE and completion of SBRT |
| LCR | 12 months and 24 months after radiotherapy | Local control rate |
| PFS | 12 months and 24 months after radiotherapy | Progress free survival |
| Frequency of AE | up to 24 months | Frequency of treatment associated adverse events |
Countries
China
Outcome results
None listed