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

NCT05057104 | Unknown

• 1 other identifier: SBRTplusTACE VS. HR
• Study Type: observational
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatocellular Carcinoma Non-resectable; Conversion

Keywords

CyberKnife; unresectable hepatocelluar carcinoma; TACE; hepatectomy; prognosis

Outcome Measures

Primary Outcomes (1)

• Overall survival time

  From date of randomization until the date of death from any cause, assessed up to 24 months.

Secondary Outcomes (3)

• 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.

• Radiation-induced liver injury rates

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

• Adverse reaction

  From the date of radiotherapy completion until the 4 months after therapy,up to 6 months

Study Arms (2)

CK-SBRT with TACE group

Conversion hepatectomy after CK-SBRT plus TACE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unresectable HCC patients meet surgical criteria after CK-SBRT plus TACE.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Related Publications (8)

• 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.

  PMID: 32767693 BACKGROUND

• 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.

  PMID: 27809890 BACKGROUND

• 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.

  PMID: 31283409 BACKGROUND

• 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.

  PMID: 29233562 BACKGROUND

• 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.

  PMID: 15273555 BACKGROUND

• 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.

  PMID: 33080748 BACKGROUND

• 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.

  PMID: 20404793 BACKGROUND

• 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.

  PMID: 31799176 BACKGROUND

Central Study Contacts

Xuezhang Duan

CONTACT

+8613621386161; duanxuezhang2006@163.com

Jing Sun

CONTACT

+8613718681094; 519299998@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 27, 2021
• Study Start: October 10, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 27, 2021

Record last verified: 2021-09