Hepatocellular Carcinoma Non-resectableNCT05057104
Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy
An observational study of Hepatocellular Carcinoma Non-resectable and Conversion, run by Beijing 302 Hospital.
Trial summary
To compare the prognosis and adverse reactions of unresectable hepatocellular carcinoma receiving stereotactic radiotherapy combined with hepatic arterial chemoembolization and conversion hepatectomy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable, Conversion
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2021to 31 Dec 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Unresectable HCC patients meet surgical criteria after CK-SBRT plus TACE.
Who may be able to join
- Unresectable HCC patients were diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
- Patients who received SBRT plus TACE have tumor regression, and surgical experts assess that R0 resection could be achieved
- CP-A or B classification;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- Platelet count≥50 × 109/L, white blood count≥1.5 × 109/L;
- ICG R15≤10%;
- Normal effective liver volume >30%;
- 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
- -the patients receive other treatments (such as targeted treatment, immune checkpoint inhibitors,etc) after CK-SBRT plus TACE.
Trial locations and contacts
No sites are listed yet.
About this study
To compare the prognosis and adverse reactions of unresectable hepatocellular carcinoma receiving stereotactic radiotherapy combined with hepatic arterial chemoembolization and conversion hepatectomy
- Keywords
- CyberKnife, unresectable hepatocelluar carcinoma, TACE, hepatectomy, prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CK-SBRT with TACE group | Not described | |
| Conversion hepatectomy after CK-SBRT plus TACE | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time
Measured: From date of randomization until the date of death from any cause, assessed up to 24 months.
Secondary outcomes (3)
Progression-free survival time
Measured: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 24 months.
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 posted27 Sep 2021
- Study start10 Oct 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies 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
- 320 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
- NCT05057104
- Sponsor's protocol ID
- SBRTplusTACE VS. HR
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erratum: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2020 Jul;70(4):313. doi: 10.3322/caac.21609. Epub 2020 Apr 6. No abstract available.
PubMed 32767693Su 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 27809890Wei X, Jiang Y, Zhang X, Feng S, Zhou B, Ye X, Xing H, Xu Y, Shi J, Guo W, Zhou D, Zhang H, Sun H, Huang C, Lu C, Zheng Y, Meng Y, Huang B, Cong W, Lau WY, Cheng S. Neoadjuvant Three-Dimensional Conformal Radiotherapy for Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Randomized, Open-Label, Multicenter Controlled Study. J Clin Oncol. 2019 Aug 20;37(24):2141-2151. doi: 10.1200/JCO.18.02184. Epub 2019 Jul 8.
PubMed 31283409Rim CH, Kim CY, Yang DS, Yoon WS. Comparison of radiation therapy modalities for hepatocellular carcinoma with portal vein thrombosis: A meta-analysis and systematic review. Radiother Oncol. 2018 Oct;129(1):112-122. doi: 10.1016/j.radonc.2017.11.013. Epub 2017 Dec 9.
PubMed 29233562Lau WY, Ho SK, Yu SC, Lai EC, Liew CT, Leung TW. Salvage surgery following downstaging of unresectable hepatocellular carcinoma. Ann Surg. 2004 Aug;240(2):299-305. doi: 10.1097/01.sla.0000133123.11932.19.
PubMed 15273555Tomonari T, Sato Y, Tanaka H, Tanaka T, Taniguchi T, Sogabe M, Okamoto K, Miyamoto H, Muguruma N, Saito Y, Imura S, Bando Y, Shimada M, Takayama T. Conversion therapy for unresectable hepatocellular carcinoma after lenvatinib: Three case reports. Medicine (Baltimore). 2020 Oct 16;99(42):e22782. doi: 10.1097/MD.0000000000022782.
PubMed 33080748Hoffe SE, Finkelstein SE, Russell MS, Shridhar R. Nonsurgical options for hepatocellular carcinoma: evolving role of external beam radiotherapy. Cancer Control. 2010 Apr;17(2):100-10. doi: 10.1177/107327481001700205.
PubMed 20404793Chiang CL, Chan ACY, Chiu KWH, Kong FS. Combined Stereotactic Body Radiotherapy and Checkpoint Inhibition in Unresectable Hepatocellular Carcinoma: A Potential Synergistic Treatment Strategy. Front Oncol. 2019 Nov 12;9:1157. doi: 10.3389/fonc.2019.01157. eCollection 2019.
PubMed 31799176
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy
- ClinicalTrials.gov ID
- NCT05057104
- Acronym / sponsor ID
- SBRTplusTACE VS. HR
- Keywords
- CyberKnife, unresectable hepatocelluar carcinoma, TACE, hepatectomy, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 10 Oct 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Sep 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.
To compare the prognosis and adverse reactions of unresectable hepatocellular carcinoma receiving stereotactic radiotherapy combined with hepatic arterial chemoembolization and conversion hepatectomy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CK-SBRT with TACE group | – | – |
| Conversion hepatectomy after CK-SBRT plus TACE | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unresectable HCC patients meet surgical criteria after CK-SBRT plus TACE.
Key inclusion criteria (8 listed)
- Unresectable HCC patients were diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
- Patients who received SBRT plus TACE have tumor regression, and surgical experts assess that R0 resection could be achieved
- CP-A or B classification;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- Platelet count≥50 × 109/L, white blood count≥1.5 × 109/L;
Key exclusion criteria (1 listed)
- -the patients receive other treatments (such as targeted treatment, immune checkpoint inhibitors,etc) after CK-SBRT plus TACE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival time
Time frame: From date of randomization until the date of death from any cause, assessed up to 24 months.
3 secondary outcomes
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 24 months.
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 Sep 2021.
- Background: PubMed 32767693Erratum: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2020 Jul;70(4):313. doi: 10.3322/caac.21609. Epub 2020 Apr 6. No abstract available.
- Background: 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.
- Background: PubMed 31283409Wei X, Jiang Y, Zhang X, Feng S, Zhou B, Ye X, Xing H, Xu Y, Shi J, Guo W, Zhou D, Zhang H, Sun H, Huang C, Lu C, Zheng Y, Meng Y, Huang B, Cong W, Lau WY, Cheng S. Neoadjuvant Three-Dimensional Conformal Radiotherapy for Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Randomized, Open-Label, Multicenter Controlled Study. J Clin Oncol. 2019 Aug 20;37(24):2141-2151. doi: 10.1200/JCO.18.02184. Epub 2019 Jul 8.
- Background: PubMed 29233562Rim CH, Kim CY, Yang DS, Yoon WS. Comparison of radiation therapy modalities for hepatocellular carcinoma with portal vein thrombosis: A meta-analysis and systematic review. Radiother Oncol. 2018 Oct;129(1):112-122. doi: 10.1016/j.radonc.2017.11.013. Epub 2017 Dec 9.
- Background: PubMed 15273555Lau WY, Ho SK, Yu SC, Lai EC, Liew CT, Leung TW. Salvage surgery following downstaging of unresectable hepatocellular carcinoma. Ann Surg. 2004 Aug;240(2):299-305. doi: 10.1097/01.sla.0000133123.11932.19.
- Background: PubMed 33080748Tomonari T, Sato Y, Tanaka H, Tanaka T, Taniguchi T, Sogabe M, Okamoto K, Miyamoto H, Muguruma N, Saito Y, Imura S, Bando Y, Shimada M, Takayama T. Conversion therapy for unresectable hepatocellular carcinoma after lenvatinib: Three case reports. Medicine (Baltimore). 2020 Oct 16;99(42):e22782. doi: 10.1097/MD.0000000000022782.
- Background: PubMed 20404793Hoffe SE, Finkelstein SE, Russell MS, Shridhar R. Nonsurgical options for hepatocellular carcinoma: evolving role of external beam radiotherapy. Cancer Control. 2010 Apr;17(2):100-10. doi: 10.1177/107327481001700205.
- Background: PubMed 31799176Chiang CL, Chan ACY, Chiu KWH, Kong FS. Combined Stereotactic Body Radiotherapy and Checkpoint Inhibition in Unresectable Hepatocellular Carcinoma: A Potential Synergistic Treatment Strategy. Front Oncol. 2019 Nov 12;9:1157. doi: 10.3389/fonc.2019.01157. eCollection 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma Non-resectable and Conversion, run by Beijing 302 Hospital.
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 8 inclusion and 1 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 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Xuezhang Duan (+8613621386161, duanxuezhang2006@163.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 24 months.). 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 NCT05057104, which also lists 8 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 Sep 2021.