SBRT With DIBH for HCC After TACE and Lipiodol Marking

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05021250
• Other study ID #: NCC2713
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Lipiodol marking
HCC patients treated with TACE and the tumor marked with lipiodol.

Locations

Country	Name	City	State
China	Bo Chen	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	The First Hospital of Jilin University, Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	ORR	Objective response rate	6 months after radiotherapy
Secondary	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
Secondary	LCR	Local control rate	12 months and 24 months after radiotherapy
Secondary	PFS	Progress free survival	12 months and 24 months after radiotherapy
Secondary	Frequency of AE	Frequency of treatment associated adverse events	up to 24 months