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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Enrolling

Phase 2

Conditions

Radiotherapy

Narrow Margin

Hepatocellular Carcinoma

Treatments

Radiation: Adjuvant SIB radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06205472

NCC4255

Details and patient eligibility

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.

Full description

Surgical resection is the primary treatment for HCC. However, it is associated with a high rate of recurrence and death. Based on the results of our retrospective study and phase II study, adjuvant radiotherapy is an effective, tolerable, and promising adjuvant regimen in patients with narrow-margin(<1cm) after hepatectomy. The 3-year and 5-year OS rates of 88.2% and 72.2% were significantly higher than the expected rates based on published reports and exceeded our predetermined threshold. However, there is no standard for the prescription dose. The high risk area of recurrence is mostly close to the blood vessels in the tumor bed, and simultaneously integrated boost (SIB) technique can optimize the target dose while protecting normal tissues. So, the investigators conducted this single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant SIB radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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