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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03243916
Other study ID # ChinaPLAGH-MHCC
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 6, 2017
Last updated August 6, 2017
Start date August 15, 2017
Est. completion date July 14, 2020

Study information

Verified date August 2017
Source Chinese PLA General Hospital
Contact Xiaoliang liu, MD
Phone +86 15801570739
Email szy957@aliyun.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date July 14, 2020
Est. primary completion date July 14, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Radiation:
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

Locations

Country Name City State
China Chinese PLA Gereral Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary response rate(RR) CR(complete response)+PR(partial response) 18 months
Primary overall survival(OS) Overall survival was defined as the time from enrollment to death from any cause. 26mounth
Secondary 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 36 month
Secondary Quality of life (QOL) A questionnaire with questions referred to simple assessments of physical abilities 36 month
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