Clinical trial · Observational

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

NCT05057104CI-TRIAL-00054088unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Conversion	—	UNRESOLVED	—
Hepatocellular Carcinoma Non-resectable	—	UNRESOLVED	—

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
CK-SBRT with TACE group
label
Conversion hepatectomy after CK-SBRT plus TACE

Primary outcomes (1)

measure
Overall survival time
timeFrame
From date of randomization until the date of death from any cause, assessed up to 24 months.

Secondary outcomes (3)

measure
Progression-free survival time
timeFrame
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.
measure
Radiation-induced liver injury rates
timeFrame
From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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.

References

Publications (8)

BACKGROUNDErratum: 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
BACKGROUNDSu 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
BACKGROUNDWei 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
BACKGROUNDRim 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
BACKGROUNDLau 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
BACKGROUNDTomonari 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.