Hepatocellular Carcinoma
Conditions
Keywords
interventional therapy, TACE, Cyberknife
Brief 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.
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
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response rate(RR) | 18 months | CR(complete response)+PR(partial response) |
| overall survival(OS) | 26mounth | Overall survival was defined as the time from enrollment to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse event(AE) | 36 month | Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause |
| Quality of life (QOL) | 36 month | A questionnaire with questions referred to simple assessments of physical abilities |
Countries
China
Contacts
Primary ContactXiaoliang liu, MD
Outcome results
None listed