Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.

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

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

Conditions6

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