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The value of temporary hepatic vein balloon embolization in the treatment of hepatocellular cancer with yttrium 90-SIRT

Evaluation of the efficacy and safety of temporary hepatic vein balloon embolization assisted with yttrium 90-SIRT in the treatment of inoperable hepatocellular carcinoma

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083970
Enrollment
Unknown
Registered
2024-05-08
Start date
2024-05-24
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

hepatocellular cancer

Interventions

Research group:Within 2 weeks before treatment, laboratory tests, 99mTc MMA hepatic artery angiography (using cone beam CT imaging), and hepatopulmonary shunt assessment (99mTc MAA, SPECT/CT) were con

Sponsors

Fujian Medical University Cancer Hospital, Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosed as primary liver cancer that cannot be surgically removed or undergo radical ablation, with liver tumors as the main cause; (2) Age = 18 years old; (3) Physical condition score ECOG = 2; (4) Expected survival period exceeds 3 months; (5) Meet the hematological indicators for treatment: hemoglobin = 90g/L, absolute neutrophil count>1500/mm ³ Platelet count = 80 × 10 °/L, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<5 times upper normal limit (ULN), total bilirubin<3 × ULN, blood creatinine<1.5 × ULN, prothrombin time (PT) or international standardized ratio (INR), activated partial thromboplastin time (APTT)<1.5 × ULN; (6) Suitable for selective arterial catheterization and angiography; (7) The maximum diameter of the tumor is greater than 8cm, or 90Y-SIRT treatment is planned, but the LSF detected by 99mTc MMA hepatic angiography is greater than 20%, or a single lung radiation dose is expected to exceed 30Gy.

Exclusion criteria

Exclusion criteria: (1) Severe liver dysfunction, including severe jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome, with a Child Pugh grade of C; (2) Incorrectable coagulation dysfunction; (3) Renal dysfunction, creatinine>176.8 µ Mol/L or creatinine clearance rate2 points, cachexia or multiple organ failure; (7) Abnormal anatomical structure of hepatic artery blood vessels, or severe uncorrectable hepatic artery portal vein fistula or hepatic artery hepatic vein shunt; (8) Cancer thrombus and embolism in the main portal vein, with less formation of collateral vessels, and inability to perform portal vein stent recanalization to restore hepatic blood flow to the main portal vein; (9) Uncorrectable hepatic gastrointestinal artery shunt; (10) Severe iodine contrast agent allergy; (11) Individuals who have used bevacizumab within 4 weeks prior to treatment; (12) Other: including pregnant or lactating women, etc

Design outcomes

Primary

MeasureTime frame
progression free survival;

Secondary

MeasureTime frame
Objective Response Rate;lung shunt fraction;

Countries

China

Contacts

Public ContactJing Feng Liu

Fujian Medical University Cancer Hospital, Fujian Cancer Hospital

drjingfeng@126.com+86 139 0502 9580

Outcome results

None listed

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