CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis

Официальное название

CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma

Обзор

The aim of our research is to evaluate the curative effect and safety of CyberKnife stereotactic body radiation therapy in treating small hepatocellular carcinoma (HCC) patients with decompensated cirrhosis.

Вмешательства

• Лучевая терапия Cyberknife stereotactic body radiation therapy
  A total dose of 45-54 Gy in 5-10 fractions was given according to the location of lesions for small HCC patients with decompensated cirrhosis.

Первичные конечные точки

• Overall survival time [Срок оценки: From date of randomization until the date of death from any cause, assessed up to 36 months]
• Progression-free survival time [Срок оценки: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months]
• Local control time [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months]

Вторичные конечные точки (2)

• Radiation-induced liver injury rates [Срок оценки: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.]
• Adverse reaction [Срок оценки: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.]

Критерии участия

Критерии включения

• Primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
• Unfeasible or refusing to undergo other treatments;
• Residual normal liver volume ≥700 cc;
• With decompensated cirrhosis (Child-Pugh B or C classification);
• Without portal vein tumor thrombus;
• Eastern Cooperative Oncology Group (ECOG) score 0-1;
• Distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm；
• Rejecting other therapies such as resection, liver transplantation, etc.
• Platelet count≥50 × 109/L, white blood count≥1.5 × 109/L;
• Patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.

Критерии исключения

• With Tumor thrombus；
• With extrahepatic metastasis;
• With lymph node involvement.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Beijing 302 hospital — Пекин

Публикации

• Sun J, Zhang A, Li W, Wang Q, Wang J, Fan Y, Sun Y, Li D, Zhang D, Duan X. CyberKnife Stereotactic Body Radiation Therapy as an Effective Treatment for Hepatocellular Carcinoma Patients With Decompensated Cirrhosis. Front Oncol. 2020 Feb 25;10:100. doi: 10.3389/fonc.2020.00100. eCollection 2020. PMID 32158688
• Culleton S, Jiang H, Haddad CR, Kim J, Brierley J, Brade A, Ringash J, Dawson LA. Outcomes following definitive stereotactic body radiotherapy for patients with Child-Pugh B or C hepatocellular carcinoma. Radiother Oncol. 2014 Jun;111(3):412-7. doi: 10.1016/j.radonc.2014.05.002. Epub 2014 Jun 3. PMID 24906626
• Granito A, Bolondi L. Non-transplant therapies for patients with hepatocellular carcinoma and Child-Pugh-Turcotte class B cirrhosis. Lancet Oncol. 2017 Feb;18(2):e101-e112. doi: 10.1016/S1470-2045(16)30569-1. PMID 28214411
• Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081. PMID 20879569
• Huertas A, Baumann AS, Saunier-Kubs F, Salleron J, Oldrini G, Croise-Laurent V, Barraud H, Ayav A, Bronowicki JP, Peiffert D. Stereotactic body radiation therapy as an ablative treatment for inoperable hepatocellular carcinoma. Radiother Oncol. 2015 May;115(2):211-6. doi: 10.1016/j.radonc.2015.04.006. Epub 2015 May 28. PMID 26028227

Идентификаторы

NCT: NCT04512833 · decompensated cirrhosis HCC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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