Clinical trial NCT05057104: Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy
Official title: Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma Non-resectable
Conversion
Keywords: CyberKnife
unresectable hepatocelluar carcinoma
TACE
hepatectomy
prognosis
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unresectable HCC patients meet surgical criteria after CK-SBRT plus TACE.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival time
timeFrame: From date of randomization until the date of death from any cause, assessed up to 24 months.
Secondary outcomes:
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.
measure: Adverse reaction
timeFrame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months
Other outcomes:
Locations:
Study officials:
References:
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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.
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citation: 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.