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Status unknownNCT03243916Updated Aug 9, 2017

Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of MHCC

An interventional study of TACE plus Cyber knife in Hepatocellular Carcinoma, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-09.

Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Hepatocellular carcinoma is a highly malignant tumor that is progressing rapidly. Hepatic arterial embolization chemotherapy (TACE) is a common method for the treatment of unresectable of hepatocellular carcinoma.But for patients with > 10cm hepatocellular carcinoma, the intervention effect was not satisfied.The cyberknife is a kind of stereotactic radiotherapy which can track the movement of tumor and monitor the position deviation of tumor in real time.This stuy is aimed to observe the efficiency and safety of the combination of TACE and cyberknife in the treatment of massive hepatocellular carcinoma.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • interventional therapy
  • TACE
  • Cyberknife
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's planned enrollment of 40 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically or cytologically confirmed hepatocellular carcinoma
  • No lymph node metastasis or distant metastasis
  • Tumor diameter at least 10 cm
  • Hepatic lesions are not suitable for surgical resection or the patient refuse to surgical treatment
  • Eastern Clinical Oncology Group (ECOG)score is 0， 1or2
  • No history of abdominal radiotherapy
  • Inoperable and untransplantable,Child-pugh score A or B
  • Normal liver volume exceeds 700 cm3

Exclusion criteria

Exclusion Criteria:

  • Previous history of abdominal radiotherapy;
  • The maximum diameter of tumor is less than 10cm;
  • The liver Child is graded C;
  • Contraindication for radiotherapy;
  • Active gastrointestinal bleeding occurred within 2 weeks before enrollment
  • Pregnancy
  • Undergoing chemotherapy throughout the past six months
  • Diffuse hepatocellular carcinoma
  • Main portal vein tumor embolization
  • Undergoing other simultaneous treatment
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    combination

    TACE plus cyber knife

    Radiation: TACE plus Cyber knife

Interventions

  • RadiationTACE plus Cyber knife

    Patients with histologically confirmed MHCC(Massive Hepatocellular Carcinoma) will receive TACE therapy,after 1 or 2 week's recovery from hepatic insufficiency ,the targeted and staged cyber knife will be given

06

What researchers measure

Primary outcomes

  1. response rate(RR)

    CR(complete response)+PR(partial response)

    Time frame: 18 months

  2. overall survival(OS)

    Overall survival was defined as the time from enrollment to death from any cause.

    Time frame: 26mounth

Secondary outcomes

  1. adverse event(AE)

    Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause

    Time frame: 36 month

  2. Quality of life (QOL)

    A questionnaire with questions referred to simple assessments of physical abilities

    Time frame: 36 month

07

Study locations

1 site
  • Chinese PLA Gereral Hospital
    Beijing, Beijing 100000, China
    • Yu Li, MD · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03243916
Lead sponsor
Chinese PLA General Hospital
Responsible party
YuLi (Vice Director of Department of Radiotherappy, Chinese PLA General Hospital) — Principal investigator
First posted
Aug 9, 2017
Start date
Aug 15, 2017 (estimated)
Primary completion
Jul 14, 2019 (estimated)
Completion
Jul 14, 2020 (estimated)
Last update
Aug 9, 2017

Study contacts

Xiaoliang liu, MD
Contact
szy957@aliyun.com
+86 15801570739
Yu Li, MD
principal investigator · China PLA hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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