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Small particle size (40-90µm) Vispearl® drug-loaded microspheres TACE combined with HAIC and systemic therapy (targeted therapy combined with immunotherapy) for the single-arm exploratory clinical study of transforming unresectable hepatocellular carcinoma

Small particle size (40-90µm) Vispearl® drug-loaded microspheres TACE combined with HAIC and systemic therapy (targeted therapy combined with immunotherapy) for the single-arm exploratory clinical study of transforming unresectable hepatocellular carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102599
Enrollment
Unknown
Registered
2025-05-16
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Unresectable liver cancer: 1. Unresectable in the sense of surgery, including the patient's overall condition that cannot tolerate surgical trauma, intolerable liver function, insufficient future liver remnant (FLR), etc. (referred to as unresectable in surgery for short). 2. Technically resectable, but no better therapeutic effect can be achieved after resection than non-surgical treatment (refer

Interventions

TACE:Vispearl Radiopaque Drug-eluting Microspheres for TACE

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 75 years old, no restriction on gender; 2.Patients with hepatocellular carcinoma diagnosed according to the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2024 edition) or confirmed by pathological histology or cytology examination; 3. Had not received any treatment related to liver cancer in the past, including but not limited to systemic therapy, local treatment, liver cancer resection, etc.; 4.Patients with unresectable CNLC Ia-IIIa stage; 5.function classified as Child-Pugh A or B (7~8 points); 6.Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0~1; 7.According to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), the patient has at least one measurable tumor lesion; 8.Participants who agree to take part in this clinical trial and voluntarily sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.The subject has previously received anti-treatment, such as: surgical resection, local treatment (interventional embolization chemotherapy, radiotherapy, ablation), systemic therapy, etc. 2.Patients with extrahepatic metastasis of hepatocellular carcinoma; 3.The lesion accounts for more than 70% of the liver volume; 4.Severe liver dysfunction (Child-Pugh Class C), including jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome; 5.Renal dysfunction: serum creatinine >176.8 µmol/L or creatinine clearance = 2, cachexia or multi-organ failure; 11.Known severe iodine contrast agent or embolic material allergy; 12.Patients with contraindications to systemic therapy drugs; 13.Pregnant/lactating women, or those planning to conceive; 14.Patients who are currently participating in other drug or device clinical trials, have not yet withdrawn, or have withdrawn for less than 1 month; 15.Persons without independent decision-making capacity or mental illness patients; 16.Researchers believe other patients unsuitable for participation in this clinical trial;

Design outcomes

Primary

MeasureTime frame
Conversion removal rate;

Countries

China

Contacts

Public ContactXin Zheng

The First Affiliated Hospital of Xi'an Jiaotong University

zhengxin@xjtufh.edu.cn+86 29 8532 3215

Outcome results

None listed

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