Clinical trial NCT05021250: SBRT With DIBH for HCC After TACE and Lipiodol Marking
Official title: Stereotactic Body Radiation Therapy With Deep Inspiration Breath Hold for Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization and Lipiodol Marking
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma, TACE, SBRT, DIBH
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: The First Hospital of Jilin University
name: Tianjin Medical University Cancer Institute and Hospital
First posted: 2021-08-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH which was registrated with lipiodol.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recognition of lipiodol marking
timeFrame: During the radiotherapy
measure: ORR
timeFrame: 6 months after radiotherapy
Secondary outcomes:
measure: Completion rate of treatment model
timeFrame: 1 months after TACE
measure: LCR
timeFrame: 12 months and 24 months after radiotherapy
measure: PFS
timeFrame: 12 months and 24 months after radiotherapy
measure: Frequency of AE
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bo Chen
state: Beijing
Study officials:
affiliation: National Cancer Center/Cancer Hospital
name: Bo Chen
role: PRINCIPAL_INVESTIGATOR
References: