A Prospective Single-arm Study on Targeted and Staged Cyber Knife Combined With Interventional Therapy in the Treatment of Massive Hepatocellular Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- response rate(RR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
combination
TACE plus cyber knife
Intervention: TACE plus Cyber knife (Radiation)
Outcomes
Primary Outcomes
response rate(RR)
Time Frame: 18 months
CR(complete response)+PR(partial response)
overall survival(OS)
Time Frame: 26mounth
Overall survival was defined as the time from enrollment to death from any cause.
Secondary Outcomes
- adverse event(AE)(36 month)
- Quality of life (QOL)(36 month)
Investigators
YuLi
Vice Director of Department of Radiotherappy
Chinese PLA General Hospital