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A clinical study for CalliSpheres drug-eluting microspheres for transcatheter arterial embolization in the downstaging therapy followed by liver transplantation for patients with hepatocellular carcinoma exceeding Milan Criteria

A clinical study for CalliSpheres drug-eluting microspheres for transcatheter arterial embolization in the downstaging therapy followed by liver transplantation for patients with hepatocellular carcinoma exceeding Milan Criteria

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022225
Enrollment
Unknown
Registered
2019-03-30
Start date
2019-04-18
Completion date
Unknown
Last updated
2019-04-01

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

Conditions

liver cancer

Interventions

Case series:CalliSpheres drug-eluting microspheres for transcatheter arterial embolization

Sponsors

Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) aged 18-70 years, gender not limited; 2) HCC diagnosed by pathology or AASLD standard; 3) excess Milan standard (Milan standard: if the tumor diameter is less than or equal to 5cm, or if there are 2 ~ 3 tumor bodies at the same time and the maximum diameter of the tumor body is less than or equal to 3cm, without invasion of large blood vessels and intrahepatic and extrahepatic metastasis), the patients who are expected to receive liver transplantation are required to receive liver transplantation. 4) understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) invasion of large blood vessels; 2) the presence of extrahepatic metastasis; 3) receive other therapeutic methods (such as RFA); 4) decompensation of liver function (bilirubin >3mg/dl, AST/ALT>5 times the upper limit or >250U/l); 5) ECOG score >2 points. 6) contraindications to angiography.

Design outcomes

Primary

MeasureTime frame
rate of downstaging;relapse free survival;

Secondary

MeasureTime frame
????????;Microsphere distribution region;Tumor response rate imaging (mRECIST) was compared with tumor pathological response rate;

Countries

China

Contacts

Public ContactXie Ping
haoYanx@163.com+86 18981838677

Outcome results

None listed

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