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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025613
Enrollment
Unknown
Registered
2019-09-02
Start date
2019-08-21
Completion date
Unknown
Last updated
2019-09-02

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

Conditions

Hepatocellular Carcinoma

Interventions

experimental group:polylactic acid embolic microspheres

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 80 years (including 80 years old), gender is not limited; (2) According to the standard of diagnosis and treatment of primary liver cancer (2018 edition), the clinical stage is primary stage Ia-IIIa; (3) ECOG score <= 2; (4) In the past 2 months, there was no use of chemotherapy, molecular targeted drugs, and Chinese herbal medicines with anticancer effects. (5) No surgery, radiotherapy, ablation and immunotherapy for liver tumors; (6) Good liver function (Child-Pugh A-B grade). (7) The patient was able to understand the purpose of the trial, voluntarily signed the informed consent form, and agreed to receive the last 3 months of imaging follow-up.

Exclusion criteria

Exclusion criteria: (1) Female patients during pregnancy and lactation; (2) white blood cells =10 points; (5) renal dysfunction (creatinine > 2mg / dl or creatinine clearance 51.3umol / L; (9) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 × ULN (upper normal limit) or > 250 U / L, still >= 2 × after liver and antiviral treatment for 1 week ULN; (10) Those who are allergic to contrast agents and embolic agents; (11) The proportion of tumors in the whole liver is >=70%; (12) Patients with central portal vein fistula; (13) Patients who are participating in clinical trials of other drugs or devices.

Design outcomes

Primary

MeasureTime frame
Objective response rate of tumor;

Secondary

MeasureTime frame
Surgical success rate;Incidence of severe adverse events (SAE);Alpha-fetoprotein changes;

Countries

China

Contacts

Public ContactLi Maoquan

Shanghai Tenth People's Hospital

cjr.limaoquan@vip.163.com+86 0534-5670220

Outcome results

None listed

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