Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Phase 2
Started
2024-01-26
Last updated
2024-01-16
Condition(s) studied
Hepatocellular CarcinomaNarrow MarginRadiotherapy
Investigational drug(s) / intervention(s)
Adjuvant SIB radiotherapy
Adjuvant SIB radiotherapy: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (\< 1 cm)
* Age \> 18 years
* Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1
* Child-Push Score: A5-A6
* Estimated life expectancy \> 3 months
* No distant metastasis (M0)
* Blood routine examination: Hb≥80g/L, ANC≥1.0x10\^9/L, PLT≥50x10\^9/L
* Hepatic function: alanine transaminase(ALT) and aspartate transaminase(AST) ≤1.5 times ULN; or ALT ≤ULN and AST ≤6 times ULN exclude possibility of heart disease
* Renal function: creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN
* Voluntary to participate and sign informed consent
Exclusion Criteria:
* History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
* Had prior abdominal irradiation
* Had prior liver transplantation
* Had serious myocardial disease or renal failure
* Had moderate or severe ascites with obvious symptoms
* Duration from surgery ≥ 3 months
Primary outcome measure(s)
The 3-year Overall Survival — up to 36 months The 3-year overall survival was calculated from the date of surgical resection to the date of death from any cause.
Trial sites (1)
Facility
City
Region
Status
Bo Chen
Beijing
China
Recruiting
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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