SBRT With DIBH for HCC After TACE and Lipiodol Marking

NCT ID: NCT05021250

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2024-04-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lipiodol marking

HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH.

Group Type: EXPERIMENTAL

Lipiodol marking

Intervention Type: PROCEDURE

HCC patients treated with TACE and the tumor marked with lipiodol.

Interventions

Lipiodol marking

HCC patients treated with TACE and the tumor marked with lipiodol.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

BO CHEN

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Chen

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center/Cancer Hospital

Locations

Bo Chen

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

NCC2713

Identifier Type: -

Identifier Source: org_study_id