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A Single-Center, Open-Label Clinical Study of SBRT Combined with Low-Dose Radiotherapy in Synergy with Targeted Immunotherapy and Polyinosinic-Polycytidylic Acid to Enhance the Efficacy of Hepatocellular Carcinoma Treatment

A Single-Center, Open-Label Clinical Study of SBRT Combined with Low-Dose Radiotherapy in Synergy with Targeted Immunotherapy and Polyinosinic-Polycytidylic Acid to Enhance the Efficacy of Hepatocellular Carcinoma Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111049
Enrollment
Unknown
Registered
2025-10-24
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatobiliary carcinoma

Interventions

SBRT combined with low-dose radiotherapy + targeted immunotherapy:low-dose radiotherapy targeted immunotherapy
SBRT combined with low-dose radiotherapy + targeted immunotherapy + polyinosinic-polycytidylic acid:low-dose radiotherapy targeted immunotherapy Polymyocytoid injection is injected subcutaneously in t

Sponsors

Mengchao Hepatobiliary Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. voluntarily enrolled in this study and signed an informed consent form; 2. aged 18-75 years old, male or female; 3. patients with unresectable intermediate and advanced hepatocellular carcinoma with multiple foci diagnosed by imaging (CT/MRI) or histopathological/cytological examination, with disease progression or treatment resistance after previous local treatment (TACE/HAIC) and/or first-line systemic therapy; 4. have at least 1 imaging measurable lesion according to the solid tumour efficacy evaluation criteria RECIST v1.1; 5. fulfil the following biochemical parameters: creatinine clearance >= 60 ml/min, child-pugh grade A to B; 6. Expected survival >= 6 months; 7. Meet other indications for receiving radiotherapy.

Exclusion criteria

Exclusion criteria: 1. patients with HIV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease, or other conditions deemed by the investigator to be ineligible for enrolment; 2. patients with a history of bone marrow or organ transplantation; 3. patients with secondary brain metastases; 4. subjects with immunodeficiency diseases or autoimmune diseases; 5. Those who are clearly allergic or potentially allergic to, or intolerant of, the components of Polymyxin Injection, Immune Checkpoint Inhibitors; 6. Pregnant or lactating women; 7. Substance abuse, clinical or psychological or social factors that compromise informed consent or study conduct; 8. any uncertainty that has an impact on patient safety or compliance.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Progression-free survival;Duration of remission;Time to treatment remission;Disease control rate;9-month survival rate;12-month survival rate;overall survival;

Countries

China

Contacts

Public ContactJi Hongbing

Mengchao Hepatobiliary Hospital of Fujian Medical University

fjjhb8@sina.com.cn+86 591 8811 6158

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026