Small Hepatocellular CarcinomaNCT04161287
Comparison of Efficacy in SBRT of HCC ≤5 cm With or Without TACE
An observational study of Small Hepatocellular Carcinoma and Stereotactic Body Radiation Therapy, run by Beijing 302 Hospital at 1 site in China.
Trial summary
The study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Small Hepatocellular Carcinoma, Stereotactic Body Radiation Therapy, Transcatheter Arterial Chemoembolization
- What is being tested?
- transcatheter arterial chemoembolization
- Type of treatment
- Surgery or procedure
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2019to 11 Jan 2025
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hepatocellular carcinoma patients whose lesion diameter ≤ 5.0 cm
Who may be able to join
- primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
- single lesion and longest tumor diameter ≤ 5.0 cm
- CP-A or B classification
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm
- unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc.
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- rejecting other therapies such as resection, liver transplantation, etc.
- platelet count≥50 × 109/L, white blood count≥1.5 × 109/L
- patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.
Who cannot join
- tumor thrombus
- lymph node involvement
- extrahepatic metastasis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Medical Center of PLA General Hospital (Beijing 302 hospital)
Beijing, 100039
Jing Sun, +8613718681094 ext. +8613718681094, 519299998@qq.com
Xuezhang s Duan, 8613621386161 ext. 8613621386161, duanxuezhang2006@163.com
About this study
Official title: Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Hepatocellular Carcinoma ≤5 cm With or Without Transcatheter Arterial Chemoembolization (TACE)
The study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.
- Conditions
- Small Hepatocellular Carcinoma, Stereotactic Body Radiation Therapy, Transcatheter Arterial Chemoembolization
- Being tested
- transcatheter arterial chemoembolization
- Keywords
- CyberKnife, SBRT, TACE, prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter arterial chemoembolizationProcedure or surgery
The hepatocellular carcinoma patients (≤5cm）who received SBRT are devided into two groups: with TACE and SBRT alone.
| Study group | Role | What they receive |
|---|---|---|
| SBRT with TACE | Not described Receives: Procedure: transcatheter arterial chemoembolization | |
| SBRT alone | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rates
OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.
Measured: From date of randomization until the date of death from any cause, assessed up to 36 months
Progression-free survival rates
PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.
Measured: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months
Local control rates
LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes (2)
Radiation-induced liver injury rates
Measured: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Adverse reaction
Measured: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start11 Oct 2019
- Primary completion11 Dec 2023
- Study completion11 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Small Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuezhang Duan, PH.D, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161287
- Sponsor's protocol ID
- JingSun
- Status last verified
- Mar 2023
- First submitted
- 7 Nov 2019
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun J, Zhang T, Wang J, Li W, Zhang A, He W, Zhang D, Li D, Ding J, Duan X. Biologically effective dose (BED) of stereotactic body radiation therapy (SBRT) was an important factor of therapeutic efficacy in patients with hepatocellular carcinoma (</=5 cm). BMC Cancer. 2019 Aug 28;19(1):846. doi: 10.1186/s12885-019-6063-9.
PubMed 31455251Zhang T, Sun J, He W, Li H, Piao J, Xu H, Duan X. Stereotactic body radiation therapy as an effective and safe treatment for small hepatocellular carcinoma. BMC Cancer. 2018 Apr 20;18(1):451. doi: 10.1186/s12885-018-4359-9.
PubMed 29678159Su TS, Lu HZ, Cheng T, Zhou Y, Huang Y, Gao YC, Tang MY, Jiang HY, Lian ZP, Hou EC, Liang P. Long-term survival analysis in combined transarterial embolization and stereotactic body radiation therapy versus stereotactic body radiation monotherapy for unresectable hepatocellular carcinoma >5 cm. BMC Cancer. 2016 Nov 3;16(1):834. doi: 10.1186/s12885-016-2894-9.
PubMed 27809890Wong TC, Chiang CL, Lee AS, Lee VH, Yeung CS, Ho CH, Cheung TT, Ng KK, Chok SH, Chan AC, Dai WC, Wong FC, Luk MY, Leung TW, Lo CM. Better survival after stereotactic body radiation therapy following transarterial chemoembolization in nonresectable hepatocellular carcinoma: A propensity score matched analysis. Surg Oncol. 2019 Mar;28:228-235. doi: 10.1016/j.suronc.2019.01.006. Epub 2019 Jan 29.
PubMed 30851906Takayasu K, Arii S, Kudo M, Ichida T, Matsui O, Izumi N, Matsuyama Y, Sakamoto M, Nakashima O, Ku Y, Kokudo N, Makuuchi M. Superselective transarterial chemoembolization for hepatocellular carcinoma. Validation of treatment algorithm proposed by Japanese guidelines. J Hepatol. 2012 Apr;56(4):886-92. doi: 10.1016/j.jhep.2011.10.021. Epub 2011 Dec 13.
PubMed 22173160
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Hepatocellular Carcinoma ≤5 cm With or Without Transcatheter Arterial Chemoembolization (TACE)
- ClinicalTrials.gov ID
- NCT04161287
- Acronym / sponsor ID
- JingSun
- Conditions
- Small Hepatocellular Carcinoma, Stereotactic Body Radiation Therapy, Transcatheter Arterial Chemoembolization
- Keywords
- CyberKnife, SBRT, TACE, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Jan 2025 (estimated)
- First posted
- 13 Nov 2019 (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.
The study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT with TACE | – | Procedure: transcatheter arterial chemoembolization |
| SBRT alone | – | – |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hepatocellular carcinoma patients whose lesion diameter ≤ 5.0 cm
Key inclusion criteria (9 listed)
- primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
- single lesion and longest tumor diameter ≤ 5.0 cm
- CP-A or B classification
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm
Key exclusion criteria (3 listed)
- tumor thrombus
- lymph node involvement
- extrahepatic metastasis
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 |
|---|---|---|
| transcatheter arterial chemoembolizationThe hepatocellular carcinoma patients (≤5cm）who received SBRT are devided into two groups: with TACE and SBRT alone. | Procedure or surgery | SBRT with TACE |
Primary outcome
Overall survival rates
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months
OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.
Progression-free survival rates
Time frame: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months
PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.
Local control rates
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.
2 secondary outcomes
Radiation-induced liver injury rates
Time frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Adverse reaction
Time frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Results publication: PubMed 31455251Sun J, Zhang T, Wang J, Li W, Zhang A, He W, Zhang D, Li D, Ding J, Duan X. Biologically effective dose (BED) of stereotactic body radiation therapy (SBRT) was an important factor of therapeutic efficacy in patients with hepatocellular carcinoma (</=5 cm). BMC Cancer. 2019 Aug 28;19(1):846. doi: 10.1186/s12885-019-6063-9.
- Results publication: PubMed 29678159Zhang T, Sun J, He W, Li H, Piao J, Xu H, Duan X. Stereotactic body radiation therapy as an effective and safe treatment for small hepatocellular carcinoma. BMC Cancer. 2018 Apr 20;18(1):451. doi: 10.1186/s12885-018-4359-9.
- Results publication: PubMed 27809890Su TS, Lu HZ, Cheng T, Zhou Y, Huang Y, Gao YC, Tang MY, Jiang HY, Lian ZP, Hou EC, Liang P. Long-term survival analysis in combined transarterial embolization and stereotactic body radiation therapy versus stereotactic body radiation monotherapy for unresectable hepatocellular carcinoma >5 cm. BMC Cancer. 2016 Nov 3;16(1):834. doi: 10.1186/s12885-016-2894-9.
- Results publication: PubMed 30851906Wong TC, Chiang CL, Lee AS, Lee VH, Yeung CS, Ho CH, Cheung TT, Ng KK, Chok SH, Chan AC, Dai WC, Wong FC, Luk MY, Leung TW, Lo CM. Better survival after stereotactic body radiation therapy following transarterial chemoembolization in nonresectable hepatocellular carcinoma: A propensity score matched analysis. Surg Oncol. 2019 Mar;28:228-235. doi: 10.1016/j.suronc.2019.01.006. Epub 2019 Jan 29.
- Results publication: PubMed 22173160Takayasu K, Arii S, Kudo M, Ichida T, Matsui O, Izumi N, Matsuyama Y, Sakamoto M, Nakashima O, Ku Y, Kokudo N, Makuuchi M. Superselective transarterial chemoembolization for hepatocellular carcinoma. Validation of treatment algorithm proposed by Japanese guidelines. J Hepatol. 2012 Apr;56(4):886-92. doi: 10.1016/j.jhep.2011.10.021. Epub 2011 Dec 13.
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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.
Xuezhang Duan, PH.D principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Hepatocellular Carcinoma and Stereotactic Body Radiation Therapy, run by Beijing 302 Hospital 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 9 inclusion and 3 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 2 Feb 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?
Contact Jing Sun, Master (+8613718681094 ext. +8613718681094, 519299998@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rates (time frame: From date of randomization until the date of death from any cause, assessed up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161287, which also lists 5 linked publications.
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 2 Feb 2024.