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Clinical application research of drug-eluting beads transarterial chemoembolization with CalliSpheres beads for advanced hepatocellular carcinoma with portal vein tumor thrombus

Clinical application research of drug-eluting beads transarterial chemoembolization with CalliSpheres beads for advanced hepatocellular carcinoma with portal vein tumor thrombus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018035
Enrollment
Unknown
Registered
2018-08-27
Start date
2018-10-01
Completion date
Unknown
Last updated
2018-09-03

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

Conditions

Hepatocellular Carcinoma

Interventions

Sponsors

the First Affiliated Hospital,College of Medicine,Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of unresectable Hepatocellular Carcinoma; 2. BCLC Staging as C period; 3. Child-pugh liver function Rating: A level, B level (= score 7); 4. aged 18-80 years male and female; 5. ECOG (Eastern Cooperative Oncology Group) 0~2; 6. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function ). For example: HB=90 g/L, ANC>1.5×10^9/L; PLT>50×10^9/L, TBIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value(Liver metastasis:<5×ULN), and CR=1.25 ×ULN; 7. Signed the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. patients with cholangiocarcinoma or combined hepatocellular-cholangiocarcinoma; 2. Those who have received previous treatments such as surgery or RFA; 3. BCLC stage D; 4. Child-Pugh C or worse B (> 7 points); 5. CT or MRI imaging findings suggest that there are obvious arteriovenous fistulas; 6. recently (= 3 months) have gastrointestinal bleeding (hematemesis or melena); 7. acccompanied with serious infections such as liver abscess; 8. acccompanied with other malignant tumors that are not effectively controlled; 9. acccompanied with HIV-infected patients; 10. The investigator judges other conditions that may affect the conduct of the clinical study and the outcome of the study.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;DCR;ORR;

Countries

China

Contacts

Public ContactTan-yang Zhou

the First Affiliated Hospital,College of Medicine,Zhejiang University

1512037@zju.edu.cn+86 15988851284

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026