Hepatocellular CarcinomaNCT04512833
CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis
An observational study of Hepatocellular Carcinoma, run by Beijing 302 Hospital at 1 site in China.
Trial summary
The aim of our research is to evaluate the curative effect and safety of CyberKnife stereotactic body radiation therapy in treating small hepatocellular carcinoma (HCC) patients with decompensated cirrhosis. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Cyberknife stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2020to 30 Aug 2026
- 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: The small HCC patients with decompensated cirrhosis who refused or were ineligible for other treatments.
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
- Unfeasible or refusing to undergo other treatments;
- Residual normal liver volume ≥700 cc;
- With decompensated cirrhosis (Child-Pugh B or C classification);
- Without portal vein tumor thrombus;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
Show all 10Show fewer
- Distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm；
- 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
- With Tumor thrombus；
- With extrahepatic metastasis;
- With lymph node involvement.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing 302 hospital
Beijing, 100039
Xuezhang Duan, +8613621386161, duanxuezhang2006@163.com
About this study
Official title: CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma
The aim of our research is to evaluate the curative effect and safety of CyberKnife stereotactic body radiation therapy in treating small hepatocellular carcinoma (HCC) patients with decompensated cirrhosis.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Cyberknife stereotactic body radiation therapy
- Keywords
- hepatocellular carcinoma, CyberKnife, stereotactic body radiation therapy, Child-Pugh B classification, Child-Pugh C classification
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyberknife stereotactic body radiation therapyRadiation
A total dose of 45-54 Gy in 5-10 fractions was given according to the location of lesions for small HCC patients with decompensated cirrhosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time
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 time
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 time
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 posted14 Aug 2020
- Study start12 Aug 2020
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2026 (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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512833
- Sponsor's protocol ID
- decompensated cirrhosis HCC
- Status last verified
- Mar 2023
- First submitted
- 11 Aug 2020
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sun J, Zhang A, Li W, Wang Q, Wang J, Fan Y, Sun Y, Li D, Zhang D, Duan X. CyberKnife Stereotactic Body Radiation Therapy as an Effective Treatment for Hepatocellular Carcinoma Patients With Decompensated Cirrhosis. Front Oncol. 2020 Feb 25;10:100. doi: 10.3389/fonc.2020.00100. eCollection 2020.
PubMed 32158688Culleton S, Jiang H, Haddad CR, Kim J, Brierley J, Brade A, Ringash J, Dawson LA. Outcomes following definitive stereotactic body radiotherapy for patients with Child-Pugh B or C hepatocellular carcinoma. Radiother Oncol. 2014 Jun;111(3):412-7. doi: 10.1016/j.radonc.2014.05.002. Epub 2014 Jun 3.
PubMed 24906626Granito A, Bolondi L. Non-transplant therapies for patients with hepatocellular carcinoma and Child-Pugh-Turcotte class B cirrhosis. Lancet Oncol. 2017 Feb;18(2):e101-e112. doi: 10.1016/S1470-2045(16)30569-1.
PubMed 28214411Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.
PubMed 20879569Huertas A, Baumann AS, Saunier-Kubs F, Salleron J, Oldrini G, Croise-Laurent V, Barraud H, Ayav A, Bronowicki JP, Peiffert D. Stereotactic body radiation therapy as an ablative treatment for inoperable hepatocellular carcinoma. Radiother Oncol. 2015 May;115(2):211-6. doi: 10.1016/j.radonc.2015.04.006. Epub 2015 May 28.
PubMed 26028227
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04512833
- Acronym / sponsor ID
- decompensated cirrhosis HCC
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, CyberKnife, stereotactic body radiation therapy, Child-Pugh B classification, Child-Pugh C classification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 14 Aug 2020 (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 aim of our research is to evaluate the curative effect and safety of CyberKnife stereotactic body radiation therapy in treating small hepatocellular carcinoma (HCC) patients with decompensated cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The small HCC patients with decompensated cirrhosis who refused or were ineligible for other treatments.
Key inclusion criteria (10 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
- Unfeasible or refusing to undergo other treatments;
- Residual normal liver volume ≥700 cc;
- With decompensated cirrhosis (Child-Pugh B or C classification);
- Without portal vein tumor thrombus;
Key exclusion criteria (3 listed)
- With Tumor thrombus；
- With extrahepatic metastasis;
- With lymph node involvement.
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 |
|---|---|---|
| Cyberknife stereotactic body radiation therapyA total dose of 45-54 Gy in 5-10 fractions was given according to the location of lesions for small HCC patients with decompensated cirrhosis. | Radiation | – |
Primary outcome
Overall survival time
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 time
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 time
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 27 Jun 2023.
- Results publication: PubMed 32158688Sun J, Zhang A, Li W, Wang Q, Wang J, Fan Y, Sun Y, Li D, Zhang D, Duan X. CyberKnife Stereotactic Body Radiation Therapy as an Effective Treatment for Hepatocellular Carcinoma Patients With Decompensated Cirrhosis. Front Oncol. 2020 Feb 25;10:100. doi: 10.3389/fonc.2020.00100. eCollection 2020.
- Results publication: PubMed 24906626Culleton S, Jiang H, Haddad CR, Kim J, Brierley J, Brade A, Ringash J, Dawson LA. Outcomes following definitive stereotactic body radiotherapy for patients with Child-Pugh B or C hepatocellular carcinoma. Radiother Oncol. 2014 Jun;111(3):412-7. doi: 10.1016/j.radonc.2014.05.002. Epub 2014 Jun 3.
- Results publication: PubMed 28214411Granito A, Bolondi L. Non-transplant therapies for patients with hepatocellular carcinoma and Child-Pugh-Turcotte class B cirrhosis. Lancet Oncol. 2017 Feb;18(2):e101-e112. doi: 10.1016/S1470-2045(16)30569-1.
- Results publication: PubMed 20879569Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.
- Results publication: PubMed 26028227Huertas A, Baumann AS, Saunier-Kubs F, Salleron J, Oldrini G, Croise-Laurent V, Barraud H, Ayav A, Bronowicki JP, Peiffert D. Stereotactic body radiation therapy as an ablative treatment for inoperable hepatocellular carcinoma. Radiother Oncol. 2015 May;115(2):211-6. doi: 10.1016/j.radonc.2015.04.006. Epub 2015 May 28.
- Individual participant dataSharing planned: Undecided
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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.
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 Hepatocellular Carcinoma, 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 10 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 27 Jun 2023. 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 (+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 time (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 NCT04512833, 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 27 Jun 2023.