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A prospective, small sample and observational study of TACE combined with portal vein tumor thrombus seed implantation and Lenvatinib in the treatment of HCC with portal vein tumor thrombus

A prospective, small sample and observational study of TACE combined with portal vein tumor thrombus seed implantation and Lenvatinib in the treatment of HCC with portal vein tumor thrombus

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059078
Enrollment
Unknown
Registered
2022-04-24
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-02-11

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

Conditions

Hepatocellular Carcinoma with Portal Vein Canc

Interventions

case series:TACE combined with particle implantation combined with Lenvatinib

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with hepatocellular carcinoma confirmed by histology or cytology; Or meet the clinical diagnostic criteria of liver cancer; 2. Estimated survival >= 3 months; 3. Aged 18-75; 4. The general condition is good, and the ECoG general condition score is 0-2; 5. The primary lesions in the liver were massive or nodular; 6. Accompanied by type I or type II tumor thrombus of portal vein (tumor thrombus of left main branch or right main branch or tumor thrombus of left and right main branches at the same time, but did not invade the main portal vein); 7. Liver function child a or B; Stage IIIA patients; 8. No previous history of radiotherapy, chemotherapy and biotherapy; 9. No serious complications, such as renal insufficiency and cardiac insufficiency; No serious history of iodine allergy; 10. The patients had informed consent, good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Distant metastasis of tumor except portal vein 2. Biliary obstruction caused by tumor invading biliary tract 3. Patients with known brain metastasis or symptoms of brain metastasis without further examination excluded brain metastasis 4. Diffuse tumor of liver 5. Tumor load > 50% 6. Portosystemic shunt or hepatic arteriovenous fistula are known 7. Congestive heart failure > New York Heart Association (NYHA) grade 2; Have uncontrollable hypertension 8. History of human immunodeficiency virus (HIV) infection 9. Renal failure or renal insufficiency, requiring hemodialysis or peritoneal dialysis 10. The target lesion received any previous treatment 11. Severe active clinical infection (> grade 2, nci-ctcae version 4.0), except HBV and HCV infection 12. Upper gastrointestinal bleeding or definite tendency of gastrointestinal bleeding within 4 weeks before the start of the test 13. Any contraindications to renvatinib or doxorubicin / pirarubicin 14. Pregnant or lactating subjects 15. Women of childbearing age and their spouses must take contraceptive measures 16. Other molecular targeted drugs were received within 4 weeks before the start of the trial 17. Patients who had major surgery within 4 weeks before the start of the trial (e.g. intrathoracic, abdominal or pelvic) or who had not recovered from the side effects of such surgery 18. Combined with other malignant tumors (those who have been cured 3 years ago can be included) 19. Previous systemic chemotherapy 20. Patients who have previously received radical treatment (surgery, liver transplantation, ablation) must have new target lesions when they are enrolled 21. For patients who have received TACE and other local treatment in the past, the original focus cannot be used as the target focus, and there must be a new target focus when they are enrolled

Design outcomes

Primary

MeasureTime frame
Time to progression;

Secondary

MeasureTime frame
Overall survival time;Disease control rate;

Countries

China

Contacts

Public ContactHailiang Li

Henan Cancer Hospital

cjr.lihailiang@vip.163.com+86 13903861969

Outcome results

None listed

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