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Multi-center clinical study of chemoembolization treatment of hepatocellular carcinoma (HCC) under the CPSC microsphere loaded with adriamycin CalliscpSC

Multi-center clinical study of chemoembolization treatment of hepatocellular carcinoma (HCC) under the CPSC microsphere loaded with adriamycin CalliscpSC

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036221
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-08-17
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Cancer of the liver

Interventions

Case group:Transarterial chemoembolization with epirubicin-loaded CalliSpheres microspheres

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The estimated survival time of HCC patients over 18 years old is more than 3 months; 2. Patients with BCLC stage B and BCLC stage a who are unsuitable or unwilling to receive surgical or ablation treatment; 3. Patients with child Pugh grade A or B in liver function; 4. Patients with ECoG score 0 or 1; 5. Patients who have not received chemotherapy, ablation, transarterial embolization or chemoembolization; 6. Patients and / or family members agree to join the clinical trial and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with diffuse liver cancer; 2. Patients with liver tumor volume accounting for more than 50% of the whole liver; 3. Patients with invasion of large vessels (main portal vein, primary branch of portal vein, main trunk of hepatic vein and inferior vena cava) or extrahepatic metastasis; 4. Patients with severe liver dysfunction (including transaminase more than 5 times of normal upper limit, total bilirubin > 3.0 mg / dl, refractory ascites, uncontrollable hepatic encephalopathy or hepatorenal syndrome); 5. Patients with severe blood coagulation dysfunction, which can not be corrected; 6. Leukocyte count 2 mg / dL or creatinine clearance rate < 30 ml / min); 9. Patients with severe iodine contrast medium allergy; 10. Patients with cachexia or multiple organ failure.

Design outcomes

Primary

MeasureTime frame
progression-free survival;serious adverse events;complete response rate;objective response rate;

Countries

China

Contacts

Public ContactYumin Wu

Shenzhen Second People's Hospital

11142636@qq.com+86 13554909462

Outcome results

None listed

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