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

NCT07274774 | Recruiting Phase 2

• 1 other identifier: SDZLEC2025-074-02
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

BCLC Stage C Hepatocellular Carcinoma; Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; BCLC stage C; metastasis; radiotheraphy

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

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

  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 (7)

• Progression-Free Survival (PFS)

  2 years

• Objective Response Rate (ORR)

  2 years

• Disease Control Rate (DCR)

  2 years

• Duration of Response (DoR)

  2 years

• Quality of Life (QoL)

  3 years

Other Outcomes (6)

• Patterns of Failure (exploratory)

  2 years

• Biomarker (exploratory): Hepatitis B Virus DNA Level

  2 years

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

  2 years

Study Arms (2)

Treatment

EXPERIMENTAL

SBRT + Systemic Therapy

Drug: Systemic therapy; Radiation: Radiotherapy

Control

OTHER

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.

Drug: Systemic therapy

Interventions

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

Control; Treatment

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• At least one measurable lesion per RECIST 1.1 (criteria specified).
• ECOG ≤2.
• Expected survival ≥6 months.
• Adequate organ function per protocol thresholds.
• For experimental arm candidates: active lesion count (when PET-CT used) ≤10.
• If prior initial systemic therapy given: intrahepatic disease stable ≥3 months.
• Effective contraception from consent through 1 year after treatment end.
• Ability to understand and sign consent.

You may not qualify if:

• 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.
• Uncontrolled comorbidities (e.g., uncontrolled diabetes, active peptic ulcer, severe cardiopulmonary disease).
• Active uncontrolled infection or active autoimmune disease requiring systemic therapy.
• Significant neurologic dysfunction.
• Pregnant or breastfeeding women; no effective contraception.
• Known hypersensitivity to planned drugs.
• Any other condition making participation unsuitable per investigator.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasm Metastasis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jinbo Yue, doctor

CONTACT

0531-67626442; jbyue@sdfmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department Radiation Oncology

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 10, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): November 10, 2028
• Last Updated: April 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)