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SBRT With DIBH for HCC After TACE and Lipiodol Marking

Primary Purpose

Hepatocellular Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Lipiodol marking

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, TACE, SBRT, DIBH

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinically or pathologically confirmed hepatocellular carcinoma.
ECOG 0-1.
BCLC C
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.
Expected gastric/duodenum/small intestine Dmax 25-35Gy; colon Dmax 28-38Gy. Prescription dose 40Gy/5-10f.
DIBH training prior to SBRT to achieve 36 seconds breath hold.
Life expectancy > 3 months.
Child-Pugh A5, A6 or B7.
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
Normal ECG, without severe cardiac dysfunction
Kidney function: CRE, BUN within 1.5 times of upper limit.
CBC: Hb≥80g/L，ANC≥1.0×109 /L，PLT≥40×109 /L
Without hemorrhagic tendency.
Voluntarily participate in this trial and sign consent form.

Exclusion Criteria:

Participants of other clinical trials.
History of abdomen radiation therapy or liver transplantation.
History of severe cardiovascular, kidney or liver disease.
Pregnancy or lactation.
Suspected or confirmed of drug or alcohol abuse.
History of severe mental or neurological disease, compromising the ability to consent and/or AE diagnosis.
Allergic to lipiodol.

Sites / Locations

Bo ChenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lipiodol marking

Arm Description

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

Outcomes

Primary Outcome Measures

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.

ORR

Objective response rate

Secondary Outcome Measures

Completion rate of treatment model

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

LCR

Local control rate

PFS

Progress free survival

Frequency of AE

Frequency of treatment associated adverse events

Full Information

NCT ID

NCT05021250

First Posted

June 23, 2021

Last Updated

August 23, 2021

Sponsor

Chinese Academy of Medical Sciences

Collaborators

The First Hospital of Jilin University, Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05021250

Brief Title

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 14, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

Collaborators

The First Hospital of Jilin University, Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, TACE, SBRT, DIBH

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lipiodol marking

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Lipiodol marking

Intervention Description

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

Primary Outcome Measure Information:

Title

Recognition of lipiodol marking

Description

Time Frame

During the radiotherapy

Title

ORR

Description

Objective response rate

Time Frame

6 months after radiotherapy

Secondary Outcome Measure Information:

Title

Completion rate of treatment model

Description

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

Time Frame

1 months after TACE

Title

LCR

Description

Local control rate

Time Frame

12 months and 24 months after radiotherapy

Title

PFS

Description

Progress free survival

Time Frame

12 months and 24 months after radiotherapy

Title

Frequency of AE

Description

Frequency of treatment associated adverse events

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinically or pathologically confirmed hepatocellular carcinoma. ECOG 0-1. BCLC C 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. Expected gastric/duodenum/small intestine Dmax 25-35Gy; colon Dmax 28-38Gy. Prescription dose 40Gy/5-10f. DIBH training prior to SBRT to achieve 36 seconds breath hold. Life expectancy > 3 months. Child-Pugh A5, A6 or B7. 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 Normal ECG, without severe cardiac dysfunction Kidney function: CRE, BUN within 1.5 times of upper limit. CBC: Hb≥80g/L，ANC≥1.0×109 /L，PLT≥40×109 /L Without hemorrhagic tendency. Voluntarily participate in this trial and sign consent form. Exclusion Criteria: Participants of other clinical trials. History of abdomen radiation therapy or liver transplantation. History of severe cardiovascular, kidney or liver disease. Pregnancy or lactation. Suspected or confirmed of drug or alcohol abuse. History of severe mental or neurological disease, compromising the ability to consent and/or AE diagnosis. Allergic to lipiodol.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bo Chen

Phone

8610-87788223

cbchinese@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bo Chen

Organizational Affiliation

National Cancer Center/Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bo Chen

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bo Chen, MD

Phone

008613240000876

chenboo@outlook.com

First Name & Middle Initial & Last Name & Degree

Bo Chen, MD

First Name & Middle Initial & Last Name & Degree

Huiying Zeng, MD

First Name & Middle Initial & Last Name & Degree

Liming Wang, MD

12. IPD Sharing Statement

Learn more about this trial

SBRT With DIBH for HCC After TACE and Lipiodol Marking

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