Hepatocellular CarcinomaNCT05021250
SBRT With DIBH for HCC After TACE and Lipiodol Marking
A study testing Lipiodol marking in people with Hepatocellular Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Lipiodol marking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Lipiodol marking
- Keywords
- Hepatocellular Carcinoma, TACE, SBRT, DIBH
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipiodol markingProcedure or surgery
HCC patients treated with TACE and the tumor marked with lipiodol.
| Study group | Role | What they receive |
|---|---|---|
| Lipiodol marking | Experimental | HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH. Receives: Procedure: Lipiodol marking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the radiotherapy
ORR
Objective response rate
Measured: 6 months after radiotherapy
Secondary outcomes (4)
Completion rate of treatment model
Including the success rate of lipiodol deposition at 1 months after TACE and completion of SBRT
Measured: 1 months after TACE
LCR
Local control rate
Measured: 12 months and 24 months after radiotherapy
PFS
Progress free survival
Measured: 12 months and 24 months after radiotherapy
Frequency of AE
Frequency of treatment associated adverse events
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start21 Jul 2021
- Primary completion31 Dec 2023
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH which was registrated with lipiodol.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University, Tianjin Medical University Cancer Institute and Hospital
- Responsible party
- Principal investigator, BO CHEN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Bo Chen, Principal investigator, National Cancer Center/Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021250
- Sponsor's protocol ID
- NCC2713
- Status last verified
- Jan 2024
- First submitted
- 23 Jun 2021
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy With Deep Inspiration Breath Hold for Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization and Lipiodol Marking
- ClinicalTrials.gov ID
- NCT05021250
- Acronym / sponsor ID
- NCC2713
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, TACE, SBRT, DIBH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University, Tianjin Medical University Cancer Institute and Hospital
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH which was registrated with lipiodol.
| Arm | Type | Receives |
|---|---|---|
| Lipiodol marking | Experimental | Procedure: Lipiodol markingHCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipiodol markingHCC patients treated with TACE and the tumor marked with lipiodol. | Procedure or surgery | Lipiodol marking |
Primary outcome
Recognition of lipiodol marking
Time frame: During the radiotherapy
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
Time frame: 6 months after radiotherapy
Objective response rate
4 secondary outcomes
Completion rate of treatment model
Time frame: 1 months after TACE
LCR
Time frame: 12 months and 24 months after radiotherapy
PFS
Time frame: 12 months and 24 months after radiotherapy
Frequency of AE
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Chen principal investigator
National Cancer Center/Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipiodol marking in people with Hepatocellular Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recognition of lipiodol marking (time frame: During the radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.