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A Multicenter, Prospective and Randomized Controlled Clinical Study (Degrasphere Trial II) That Comparing the Safety and Efficacy of Drug-loaded Polylactic Acid Embolized Microspheres in Treatment of Hepatocellular Carcinoma With Polyvinyl Alcohol Embolization Microspheres

A Multicenter, Prospective and Randomized Controlled Clinical Study (Degrasphere Trial II) That Comparing the Safety and Efficacy of Drug-loaded Polylactic Acid Embolized Microspheres in Treatment of Hepatocellular Carcinoma With Polyvinyl Alcohol Embolization Microspheres

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016655
Enrollment
Unknown
Registered
2018-06-14
Start date
2018-06-05
Completion date
Unknown
Last updated
2018-06-18

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

Conditions

Hepatocellular Carcinoma.

Interventions

Sponsors

Shanghai Tenth People' Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male or non-pregnant women aged 18-80 years old; 2. Hepatocellular carcinoma diagnosed according to EASL standard (single lesion = 8cm or up to 3 lesions = 3cm); 3. According to the primary diagnosis and treatment of liver cancer (2017 edition) clinical stage of Ib, IIa HCC; 4. ECOG score = 2; 5. No history of chemotherapy, radiotherapy or embolism nearly 2 months; 6. No vascular infiltration or extrahepatic proliferation; 7. Good liver function (Child-Pugh A-Child-Pugh B); 8. Patients are able to understand the purpose of the trial, sign informed consent voluntarily, and agree to undergo a 6-month follow-up of imaging.

Exclusion criteria

Exclusion criteria: 1. The investigators believe that patients who are not fit to participate in this trial; 2. Pregnancy and lactation in female patients; 3. Platelet 2mg/dl or creatinine clearance 3mg/dl; 12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 5 × ULN (upper limit of normal) or> 250 IU / L, = 2 × ULN after 1 week of liver and antiviral treatment; 13. Patients with uncontrollable or obvious heart disease, such as congestive heart failure, difficult to control supraventricular or ventricular arrhythmias, class II or more atrioventricular block, acute myocardial ischemia or prolonged QT interval, or myocardial infarction in the past 6 months; 14. Patients who have participated in other drug or instrumental clinical trials.

Design outcomes

Primary

MeasureTime frame
objective response rate;Surgical success rate;the incidence of treatment-related serious adverse events;the change of tumor marker AFP;

Countries

China

Contacts

Public ContactMaoquan Li

Shanghai Tenth People' Hospital

cjr.limaoquan@vip.163.com+86 053 45679601

Outcome results

None listed

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