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TACE plus sorafenib VS TACE monotherapy for the treatment of Multi-nodular hepatocellular carcinoma (Stage BCLC B): A prospective, multi-center comparison study

TACE plus sorafenib VS TACE monotherapy for the treatment of Multi-nodular hepatocellular carcinoma (Stage BCLC B): A prospective, multi-center comparison study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONN-16007928
Enrollment
Unknown
Registered
2016-02-16
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

Intermediate hepatocellular carcinoma

Interventions

Sponsors

Henan cancer hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. patients who had a histologically or clinically confirmed diagnosis of HCC (according to the diagnostic criteria for primary liver cancer proposed by the Chinese Ministry of Health); 2. patients diagnosed with Barcelona Clinic Liver Cancer (BCLC) stage B HCC (4=9.0g/dlNeutrophils count>=1.5*10^9/Lplatelet count>=50*10^9/L; (2) serum ALB>=28g/L; TBIL<34.2µmol/LALTAST< 5-times the upper limit of the normal range or less; (3) BunCr<1.5-times the upper limit of the normal range or less; (4) INR<1.7 or Prothrombin time <4 s above the control.

Exclusion criteria

Exclusion criteria: 1. patient who was pregnant or breastfeeding; 2. Had main portal vein obstruction and/or vascular invasion (inferior vena cava, hepatic vein); 3. Biliary obstruction caused by tumor invasion; 4. Brain metastases; 5. Diffuse lesions or lesions with less blood supplyor boundary is not clear; 6. portosystemic shunt or hepatic arteriovenous fistula; 7. Tumor burden> 50%; 8. Congestive heart failure and / or uncontrolled high blood pressure; 9. Renal failure or renal insufficiency (requiring dialysis treatment); 10. HIV infection or severe active infection (except HBV / HCV); 11. Major surgery within 4weeks prior to the study entry, or a history of gastrointestinal hemorrhage; 12. Received molecularly targeted therapy within 4weeks prior to the study entry; 13. Combined with other malignancies (within 3 years); 14. Underwent systemic chemotherapy or TACE; 15. target lesions had received any treatment.

Design outcomes

Secondary

MeasureTime frame
Time to progression;Disease control rate;

Primary

MeasureTime frame
Overall Survival time;

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 4, 2026