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A randomized controlled trial for transcatheter arterial chemoembolization (TACE) and sorafenib in hepatocellular carcinoma with portal vein cancer and non-combined stereotactic radiotherapy (SBRT) in the treatment of hepatocellular carcinoma with portal vein cancer (TACE) and the combination and disassociation of sorafenib

A randomized controlled trial for transcatheter arterial chemoembolization (TACE) and sorafenib in hepatocellular carcinoma with portal vein cancer and non-combined stereotactic radiotherapy (SBRT) in the treatment of hepatocellular carcinoma with portal vein cancer (TACE) and the combination and disassociation of sorafenib

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025300
Enrollment
Unknown
Registered
2019-08-22
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-09-16

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

Conditions

hepatocellular carcinoma

Interventions

Group A:Group sorafenib+TACE
Group B:Group sorafenib+TACE+ SBRT

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) the patient shall sign an informed consent form prior to the commencement of any research-related proceedings. The patient must understand and voluntarily sign a written informed consent form; (2) Male and female aged over 18 years old; (3) HCC patients with PVTT diagnosed by cytology or histology, or color Doppler ultrasound, CT,MRI, hepatic artery perfusion imaging and laboratory examination; (4) after multi-disciplinary consultation, it is considered that interventional therapy can be used. According to Chengundefineds classification, portal vein tumor thrombus was diagnosed as type II (tumor thrombus was in the primary branch of portal vein) or type III (tumor thrombus in portal vein trunk). There was no extrahepatic metastasis; (5) No history of abdominal radiotherapy; (6) there was no systematic treatment, including targeted therapy or systemic chemotherapy, before admission to the group; (7) Eastern Cooperative Oncology Group (ECOG) general status score of 2; (8) The expected survival time is not less than 3 months; (9) Child-Pugh class A of liver function; (10) Liver, Kidney function and the bone marrow profile should be normal, the AST was 2.5% ULN, the ALT was 2.5% ULN; the total ALT and AST were 5% ULN, the platelet count was> 70%109/ L, the hemoglobin (Hb) was higher than 9 g/ cl, the absolute value of the neutrophil (ANC)> 1500/ mm3, and the blood transfusion was not allowed to reach the entry criteria); (11) After the co-consultation with the interventional department and the radiotherapy department, it is considered that the patients who can be treated with the intervention can be treated.

Exclusion criteria

Exclusion criteria: 1. Prior acceptance of systemic chemotherapy, targeted therapy or immunotherapy, etc.; 2. A type of hepatocellular carcinoma; 3. Uncontrolled infection; 4. The malignant tumor of other organs is combined at the same time; 5. The blood system and the liver and kidney function are damaged, and the target therapy, radiotherapy and interventional therapy can not be tolerated; 6. The clinical manifestations included obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe cardiac valvular disease; 7. Serious bone marrow function failure; 8. Uncontrolled mentally ill subjects; 9. Other anti-tumor therapeutic clinical trials within 3 months; 10. Subjects with pregnancy or lactation; 11. The investigator considered it inappropriate to take part in the subject of this trial.

Design outcomes

Primary

MeasureTime frame
Disease remission rate;

Countries

China

Contacts

Public ContactXin Wang

West China Hospital, Sichuan University

wangxin213@sina.com+86 18980602291

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026