SBRT Plus Systemic Therapy vs Systemic Therapy Alone in BCLC C Hepatocellular Carcinoma

ConditionsHepatocellular Carcinoma BCLC Stage C Hepatocellular Carcinoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorShandong Cancer Hospital and Institute

About this trial

This prospective, multicenter, phase II randomized controlled trial compares the efficacy and safety of SBRT combined with systemic therapy versus systemic therapy alone in BCLC stage C hepatocellular carcinoma (HCC). The primary objective is to compare overall survival (OS) between the two arms. Secondary objectives include progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and incidence and severity of adverse events (AEs). Eligible patients will be randomized 2:1 to an experimental arm (SBRT + systemic therapy) or control arm (systemic therapy alone). Key inclusion criteria include BCLC C disease, Child-Pugh A-B liver function, ECOG ≤2, measurable disease per RECIST 1.1, and stable intrahepatic disease after initial systemic therapy for ≥3 months when applicable. The trial will also include predefined safety monitoring, QoL assessments (EORTC QLQ-C30 and QLQ-HCC18), and exploratory biomarker analyses.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-70 years.

Histologically or clinically diagnosed HCC per national guidelines.

BCLC stage C (CNLC IIIA/IIIB), including PVTT and/or extrahepatic metastases amenable to protocol procedures.

Child-Pugh class A or B (score ≤7).

Disqualifiers

Second primary malignancy (exceptions apply).

Tumor thrombus/metastases judged not amenable to radiotherapy.

Prior systemic anticancer therapy for current HCC (prior local therapy permitted per rules).

Severe organ dysfunction precluding treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

Systemic therapy
Drug
Systemic therapy will consist of the continuation of the guideline-recommended systemic treatment received prior to enrollment, in accordance with approved labels and national guidelines
Radiotherapy
Radiation
portal vein tumor thrombus (PVTT, if present) and/or limited extrahepatic active lesions. For patients presenting with more than 10 lesions at baseline (including extrahepatic metastases with or without portal vein tumor thrombus), a comprehensive FDG-PET/CT reassessment of the whole body is required after 3 months of systemic therapy. Patients who demonstrate ≤10 active lesions at this reassessment may then be considered eligible for SBRT. Dose and fractionation: total dose 25-40 Gy delivered in 5 fractions (5-8 Gy per fraction). Dose selection individualized based on tumor size, location and nearby organ-at-risk constraints; sequential or staged SBRT allowed.

Treatment groups

184 Participants

are divided into 2 treatment groups

Group A: TreatmentExperimental treatment 2 interventions

Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

Overall Survival (OS)

Time from date of randomization to date of death from any cause

Time frame

subjects will be followed up for a minimum combined accrual + follow-up period of 48 months (24-month enrollment + 24-month follow-up planned)

Secondary outcomes

Progression-Free Survival (PFS)

Time from randomization to radiographic disease progression per RECIST 1.1/mRECIST or death

Time frame

2 years

Objective Response Rate (ORR)

proportion achieving CR or PR by RECIST 1.1 and mRECIST; assessed at scheduled imaging

Time frame

2 years

Disease Control Rate (DCR)

proportion achieving CR + PR + SD

Time frame

2 years

Duration of Response (DoR)

from first documented CR/PR to progression or death

Time frame

2 years

Other outcomes

Patterns of Failure (exploratory)

description of local vs distant progression and subsequent treatments.

Time frame

2 years

Biomarker (exploratory): Hepatitis B Virus DNA Level

Quantitative assessment of HBV DNA in peripheral blood as a marker of viral replication.

Time frame

2 years

Biomarker (exploratory): Alpha-fetoprotein (AFP) Level

Serum AFP concentration measured as a tumor burden indicator.

Time frame

2 years

Biomarker (exploratory): Circulating Tumor DNA (ctDNA) Level

Quantification of tumor-derived DNA fragments in peripheral blood using next-generation sequencing.

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Cancer Hospital and Institute

Lead sponsor

Source ClinicalTrials.gov

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