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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Adjuvant SIB radiotherapy

Treatment groups

100 Participants
are divided into 1 treatment group