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OncoMatch/Clinical Trials/NCT06205472

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

Is NCT06205472 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for hepatocellular carcinoma.

Phase 2RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT06205472Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Disease stage

Excluded: Stage DISTANT METASTASIS (M1)

No distant metastasis (M0)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: hepatectomy

Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (< 1 cm)

Cannot have received: abdominal irradiation

Had prior abdominal irradiation

Cannot have received: liver transplantation

Had prior liver transplantation

Lab requirements

Blood counts

Hb≥80g/L, ANC≥1.0x10^9/L, PLT≥50x10^9/L

Kidney function

creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN

Liver 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; Child-Push Score: A5-A6

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; Child-Push Score: A5-A6; Renal function: creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN

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