Actively Recruiting
Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-01-16
100
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(\<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.
CONDITIONS
Official Title
Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of hepatocellular carcinoma after hepatectomy with narrow pathological margins (< 1 cm)
- Age over 18 years
- Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1
- Child-Pugh Score: A5-A6
- Estimated life expectancy over 3 months
- No distant metastasis (M0)
- Blood routine examination: hemoglobin 6 g/L or higher, absolute neutrophil count 1.0 x 10^9/L or higher, platelet count 50 x 10^9/L or higher
- Liver function: alanine transaminase (ALT) and aspartate transaminase (AST) no more than 1.5 times the upper limit of normal (ULN); or ALT 4 ULN and AST 6 ULN excluding heart disease
- Kidney function: creatinine (CRE) and blood urea nitrogen (BUN) no more than 1.5 times ULN
- Willing to participate and sign informed consent
You will not qualify if you...
- History of malignancies except basal cell skin carcinoma and in situ carcinoma of the cervix
- Prior abdominal irradiation
- Prior liver transplantation
- Serious myocardial disease or renal failure
- Moderate or severe ascites with obvious symptoms
- Time from surgery 3 months or more
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Bo Chen
Beijing, China
Actively Recruiting
Research Team
B
Bo Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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