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NCT Number: NCT04512833

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyberknife stereotactic body radiation therapy

Radiation

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 outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Sun

CONTACT

[email protected]

+8613718681094

Xuezhang Duan

CONTACT

[email protected]

+8613621386161

Sponsors and collaborators

Lead sponsor

Beijing 302 Hospital

Other

Registry information

Official study title

CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma

Important dates

Study start
2020
Primary completion
2023
Study completion
2026
First posted
Aug 14, 2020
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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