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| Name | Class |
|---|---|
| The First Hospital of Jilin University | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipiodol marking | Experimental | HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipiodol marking | Procedure | HCC patients treated with TACE and the tumor marked with lipiodol. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Chen | National Cancer Center/Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bo Chen | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH which was registrated with lipiodol.
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| 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 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |