Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title:

Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05057104
• Other study ID #: SBRTplusTACE VS. HR
• Status: Not yet recruiting
• Start date: October 10, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2021
• Source: Beijing 302 Hospital
• Contact: Xuezhang Duan
• Phone: +8613621386161
• Email: duanxuezhang2006[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare the prognosis and adverse reactions of unresectable hepatocellular carcinoma receiving stereotactic radiotherapy combined with hepatic arterial chemoembolization and conversion hepatectomy

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

-the patients receive other treatments (such as targeted treatment, immune checkpoint inhibitors,etc) after CK-SBRT plus TACE.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

References & Publications (8)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival time		From date of randomization until the date of death from any cause, assessed up to 24 months.
Secondary	Progression-free survival time		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.
Secondary	Radiation-induced liver injury rates		From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Secondary	Adverse reaction		From the date of radiotherapy completion until the 4 months after therapy,up to 6 months