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A Randomized Controlled Trial of cTACE and NBCA-PVE Sequential Embolizations for Unresectable Hepatocelluar Carcinama

A Randomized Controlled Trial of cTACE and NBCA-PVE Sequential Embolizations for Unresectable Hepatocelluar Carcinama

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036078
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
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

Hepatocellular carcinoma

Interventions

Experimental group:cTACE and NBCA-PVE Sequential Embolizations
Control group:cTACE

Sponsors

The Third Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old (including the threshold value),patients knew the research process and agreed to participate, and signed relevant informed consent documents; 2. Pathological or clinical diagnosis of hepatocellular carcinoma (2019 edition of the National Health Commission guidelines for diagnosis and treatment of primary liver cancer); 3. The clinical stage of liver cancer in Barcelona (BCLC) is stage A and B, and all tumors are confined to half liver; 4. There was no definite distant metastasis; 5. No other anti-tumor treatment was received in the past, and the treatment compliance was good; 6. The tumor can not be resected or liver transplantation, or patients refuse surgical treatment; 7. Good general condition (ECoG PS <=1); 8. Child-Pugh A or B.

Exclusion criteria

Exclusion criteria: 1. Diffuse invasive hepatocellular carcinoma; the tumor was more than half liver or portal vein with tumor thrombus; extrahepatic metastasis occurred; 2. History of other tumors; 3. The liver function was obviously damaged (TBIL=2.5mg/dL ALB=30g/L PLT=50*109/L INR>1.5); 4. Uncontrolled ascites or hepatic encephalopathy, severe esophageal and gastric varices or history of upper gastrointestinal bleeding; 5. There were severe chronic accompanying diseases, embolic events, psychosis, severe infection, syphilis or HIV; 6. Pregnancy or other angiographic contraindications; 7. Those who are participating in other clinical trials or have poor compliance and cannot be followed up.

Design outcomes

Primary

MeasureTime frame
Overall survival (OS) ( 2-year survival rates);

Secondary

MeasureTime frame
Time to tumor progression (TTP);Objective response rate (ORR);Conversion success rate;Disease control rate;

Countries

China

Contacts

Public ContactYang Yefa

The Third Affiliated Hospital of Naval Medical University

Yangyefa66@163.com+86 13386270636

Outcome results

None listed

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