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

NCT ID: NCT03243916

Last Updated: 2017-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2020-07-14

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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combination

TACE plus cyber knife

Group Type EXPERIMENTAL

TACE plus Cyber knife

Intervention Type RADIATION

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

Interventions

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TACE 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

Intervention Type RADIATION

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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YuLi

Vice Director of Department of Radiotherappy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu Li, MD

Role: PRINCIPAL_INVESTIGATOR

China PLA hospital

Locations

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Chinese PLA Gereral Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Xiaoliang liu, MD

Role: CONTACT

+86 15801570739

Facility Contacts

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Yu Li, MD

Role: primary

Other Identifiers

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ChinaPLAGH-MHCC

Identifier Type: -

Identifier Source: org_study_id

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