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Status unknownNCT04512833Updated Jun 27, 2023

CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis

An observational study in Hepatocellular Carcinoma, sponsored by Beijing 302 Hospital. Status unknown at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-27.

Sponsored by Beijing 302 Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • hepatocellular carcinoma
  • CyberKnife
  • stereotactic body radiation therapy
  • Child-Pugh B classification
  • Child-Pugh C classification
03

In context

Carcinoma, Hepatocellular

3,251 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 60 is below the median of 200 across 769 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Beijing 302 Hospital is the lead sponsor of 88 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The small HCC patients with decompensated cirrhosis who refused or were ineligible for other treatments.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

Exclusion Criteria:

  • With Tumor thrombus;
  • With extrahepatic metastasis;
  • With lymph node involvement.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Interventions

  • RadiationCyberknife stereotactic body radiation therapy

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months

  2. Progression-free survival time

    PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.

    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

  3. Local control time

    LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.

    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

Secondary outcomes

  1. Radiation-induced liver injury rates

    Time frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

  2. Adverse reaction

    Time frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

07

Study locations

1 of 1 sites recruiting
  • Beijing 302 hospital
    Beijing, 100039, China
    Recruiting
08

References and documents

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 32158688 ↗
  • Culleton 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 24906626 ↗
  • Granito 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 28214411 ↗
  • Benedict 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 20879569 ↗
  • Huertas 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2020 (actual). Primary completion is estimated for Aug 2023, 36 months after the start.

Of 273 non-industry observational studies under Carcinoma, Hepatocellular, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 112. This study's planned 36 months is below that.

Counting every sponsor, half of 313 studies reached it within 50 months; a quarter within 32 and three quarters within 98.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2020
First posted
Aug 14, 2020
StartActual
Aug 12, 2020
Primary completionEst.
Aug 30, 2023
CompletionEst.
Aug 30, 2026
Last update
Jun 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04512833
Lead sponsor
Beijing 302 Hospital
Responsible party
Sponsor
First posted
Aug 14, 2020
Start date
Aug 12, 2020
Primary completion
Aug 30, 2023 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Jun 27, 2023

Study contacts

Jing Sun
Contact
519299998@qq.com
+8613718681094
Xuezhang Duan
Contact
duanxuezhang2006@163.com
+8613621386161

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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