SBRT With DIBH for HCC After TACE and Lipiodol Marking

Cancer Institute and Hospital, Chinese Academy of Medical Sciences30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: During the radiotherapy

ORR

Objective response rate

Time frame: 6 months after radiotherapy

Secondary Outcomes

Completion rate of treatment model

Including the success rate of lipiodol deposition at 1 months after TACE and completion of SBRT

Time frame: 1 months after TACE

LCR

Local control rate

Time frame: 12 months and 24 months after radiotherapy

PFS

Progress free survival

Time frame: 12 months and 24 months after radiotherapy

Frequency of AE

Frequency of treatment associated adverse events

Time frame: up to 24 months