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Hepatocellular CarcinomaNCT03243916

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

A study testing TACE plus Cyber knife in people with Hepatocellular Carcinoma, run by Chinese PLA General Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
TACE plus Cyber knife
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
15 Aug 2017to 14 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Undergoing chemotherapy throughout the past six months
  • Diffuse hepatocellular carcinoma
  • Main portal vein tumor embolization
  • Undergoing other simultaneous treatment

Trial locations and contacts

1 site in 1 country.

Xiaoliang liu, MD contact

+86 15801570739

szy957@aliyun.com

China1 site

  • Chinese PLA Gereral Hospital

    Beijing, Beijing Municipality, 100000

    Yu Li, MD

Other trials in China

About this study

Official title: A Prospective Single-arm Study on Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of Massive Hepatocellular Carcinoma

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.

Being tested
TACE plus Cyber knife
Keywords
interventional therapy, TACE, Cyberknife
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TACE plus Cyber knifeRadiation

    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

Study groups in NCT03243916
Study groupRoleWhat they receive
combinationExperimentalTACE plus cyber knife
Receives: Radiation: TACE plus Cyber knife

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. response rate(RR)

    CR(complete response)+PR(partial response)

    Measured: 18 months

  2. overall survival(OS)

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

    Measured: 26mounth

Secondary outcomes (2)

  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

    Measured: 36 month

  2. Quality of life (QOL)

    A questionnaire with questions referred to simple assessments of physical abilities

    Measured: 36 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2017
  2. Study start15 Aug 2017 (estimated)
  3. Primary completion14 Jul 2019 (estimated)
  4. Study completion14 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03243916
Sponsor's protocol ID
ChinaPLAGH-MHCC
Status last verified
Aug 2017
First submitted
6 Aug 2017
Last updated
9 Aug 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing TACE plus Cyber knife in people with Hepatocellular Carcinoma, run by Chinese PLA General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaoliang liu, MD (+86 15801570739, szy957@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

response rate(RR) (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03243916.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.

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