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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04512833
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Beijing 302 Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Radiation: Cyberknife stereotactic body radiation therapy

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma
Actual Study Start Date : August 12, 2020
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : August 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis


Intervention Details:
  • Radiation: 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.


Primary Outcome Measures :
  1. Overall survival time [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 36 months ]
    OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.

  2. Progression-free survival time [ Time Frame: 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 ]
    PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.

  3. Local control time [ Time Frame: 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 ]
    LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.


Secondary Outcome Measures :
  1. Radiation-induced liver injury rates [ Time Frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. ]
  2. Adverse reaction [ Time Frame: From the date of radiotherapy completion until the 4 months after therapy,up to 6 months. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The small HCC patients with decompensated cirrhosis who refused or were ineligible for other treatments.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512833


Contacts
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Contact: Jing Sun +8613718681094 519299998@qq.com
Contact: Xuezhang Duan +8613621386161 duanxuezhang2006@163.com

Locations
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China
Beijing 302 hospital Recruiting
Beijing, China, 100039
Contact: Xuezhang Duan    +8613621386161    duanxuezhang2006@163.com   
Sponsors and Collaborators
Beijing 302 Hospital
Publications of Results:

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Responsible Party: Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT04512833    
Other Study ID Numbers: decompensated cirrhosis HCC
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing 302 Hospital:
hepatocellular carcinoma
CyberKnife
stereotactic body radiation therapy
Child-Pugh B classification
Child-Pugh C classification
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases