Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy
NCT ID: NCT05057104
Last Updated: 2021-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
320 participants
OBSERVATIONAL
2021-10-10
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CK-SBRT with TACE group
No interventions assigned to this group
Conversion hepatectomy after CK-SBRT plus TACE
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Beijing 302 Hospital
OTHER
Responsible Party
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Central Contacts
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References
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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.
Su 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.
Wei 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.
Rim 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.
Lau 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.
Tomonari 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.
Hoffe 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.
Chiang 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.
Other Identifiers
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SBRTplusTACE VS. HR
Identifier Type: -
Identifier Source: org_study_id
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