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A prospective, multi-center comparison study of transarterial chemoembolization combined with sorafenib and transarterial chemoembolization combined with 125I seed implantation for the treatment of hepatocellular carcinoma with portal vein tumor thrombosis

A prospective, multi-center comparison study of transarterial chemoembolization combined with sorafenib and transarterial chemoembolization combined with 125I seed implantation for the treatment of hepatocellular carcinoma with portal vein tumor thrombosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONN-16007929
Enrollment
Unknown
Registered
2016-02-03
Start date
2016-03-01
Completion date
Unknown
Last updated
2017-04-18

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 tumor thrombosis

Interventions

B:TACE+125I seed implantation

Sponsors

Henan Cancer hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients confirmed by histology and cytology or accord with standard of clinical diagnosis standard; 2. Expected survival time for 3 months or more; 3. Aged 18-75 years old; 4. Generally condition is good and ECOG status score 0 to 2 points; 5. Intrahepatic primary sites for giant block or nodules; 6. Accompanied by portal vein type I or II tumor emboli (left main or right main tumor emboli or at the same time there is two main branch and portal venous tumor emboli but not assault trunk); 7. patients with Child A or B liver function and BCLC stage for C and no bone, brain, lung and lymph node metastasis; 8. Without radiotherapy, chemotherapy, biological treatment history; 9. No serious complications such as renal insufficiency, cardiac insufficiency, and?no serious iodine allergy; 10. Patients with informed consent and good adherence to follow-up.

Exclusion criteria

Exclusion criteria: 1. In addition to its portal vein tumor distant metastasis; 2. Biliary tract tumor invasion to biliary obstruction; 3. Brain metastases or have symptoms of brain metastases and without further examination excluded patients; 4. Diffuse liver tumors; 5. The tumor load > 50%; 6. Portosystemic shunts or liver blood vessels - venous fistula; 7. Congestive heart failure > New York heart association (NYHA) class 2 and have no control of high blood pressure; 8. A history of human immunodeficiency virus (HIV) infection; 9. Kidney failure or renal insufficiency, and need for blood or peritoneal dialysis; 10. Target lesion before receiving any treatment; 11. Severely active clinical infection (> 2 levels, NCI CTCAE version 4.0), except for HBV and HCV infection; 12. Upper gastrointestinal bleeding within 4 weeks before starting test or there is a clear tendency of gastrointestinal bleeding; 13. Sorafenib or Doxorubicin or Pirarubicin taboo; 14. The patient in pregnancy or breastfeeding; 15. Women in childbearing age and the spouses ?must be taken?contraceptive measures; 16. Within 4 weeks before start test received other molecular targeted drugs treatment; 17. Four weeks before ?experimenting began?there were ?surgery ?(eg: in the chest and abdominal or pelvic cavity) or has not yet recovered from a side effect of this kind of surgery patients; 18. With other malignant tumors ( have cured three years ago can be included); 19. Previons received systemic chemotherapy; 20. Previons treated with radical therapy (surgery, liver transplantation, ablation) patients must have a new target lesions; 21. Previous received TACE treatment, the original lesions was not as target lesions, the group must have a new target lesions.

Design outcomes

Primary

MeasureTime frame
Overall Survival;

Countries

China

Contacts

Public ContactHailiang Li
cjr.lihailiang@vip.163.com+86 13903861969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026