SBRT With DIBH for HCC After TACE and Lipiodol Marking

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: Lipiodol marking

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo Chen; Phone Number: 8610-87788223; Email: cbchinese@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Bo Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lipiodol marking; HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH.	Procedure: Lipiodol marking; HCC patients treated with TACE and the tumor marked with lipiodol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Tianjin Medical University Cancer Institute and Hospital; The First Hospital of Jilin University
• Investigators: Principal Investigator: Bo Chen, National Cancer Center/Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma, TACE, SBRT, DIBH
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Antineoplastic Agents; Ethiodized Oil
• Other Study ID Numbers: NCC2713

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No