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CalliSpheres drug-loadable embolic microspheres combined with microwave ablation for the treatment of ultra-UCSF

CalliSpheres drug-loadable embolic microspheres combined with microwave ablation for the treatment of ultra-UCSF

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100044383
Enrollment
Unknown
Registered
2021-03-17
Start date
2021-03-20
Completion date
Unknown
Last updated
2021-09-07

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

Conditions

Primary liver cancer

Interventions

experimental group:DEB-TACE combined with microwave ablation therapy
control group:C-TACE combined with microwave ablation therapy

Sponsors

Qingdao University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 70 years old; strictly in line with "Primary Liver Cancer Diagnosis and Treatment Standards" (2017 Annual version) HCC patients diagnosed by clinical diagnostic criteria or histopathological or cytological examinations; (2) Exceed the UCSF standard (a single tumor diameter = 90 g/L; ANC >= 1.5x10^9/L; PLT >= 80x10^9/L; 2) The biochemical inspection shall meet the following standards: ALB >= 29g/L; ALT and AST 45ml/min (Cockcroft-Gault formula); 3) Remnant liver volume: normal liver RLV/SLV > 20%, cirrhotic liver RLV/SLV>40%; 4) The patient is expected to survive more than 3 months. The subject voluntarily joined the study and signed an informed consent form, Good compliance and follow-up cooperation.

Exclusion criteria

Exclusion criteria: (1) Extrahepatic metastasis of primary liver cancer, invasion of major blood vessels such as the main portal vein and hepatic vein; (2) Diffuse liver cancer; (3) Patients with myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval) >=470ms); (4) According to NYHA standards, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination reveals left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy; (6) Those considered by the researcher to be unsuitable for inclusion in the group; (7) Pregnant or breast-feeding women; those with fertility who are unwilling or unable to take effective contraceptive measures; Have a mental illness or a history of psychotropic drug abuse; (8) Patients with combined HIV infection; (9) A history of liver resection, liver transplantation, interventional therapy, and other malignant tumors; (10) Patients with active infection; (11) Contraindications for TACE, Pirubicin, and microwave ablation; (12) Patients with poor compliance such as floating population; (13) Participants in clinical trials of other experimental drugs or devices within four weeks.

Design outcomes

Primary

MeasureTime frame
Downtime success rate;

Secondary

MeasureTime frame
Tumor-free survival;Disease-free survival;

Countries

China

Contacts

Public ContactChunpeng Yu

Qingdao University Affiliated Hospital

Baidanbai01240@sina.com+86 13406801339

Outcome results

None listed

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