Hepatocellular Carcinoma
Conditions
Interventions
Research group: low-dose maintenance therapy with thalidomide as the main triple oral regimen for advanced hepatocellular carcinoma after TACE
Control group:TACE for advanced hepatocellular carcinoma
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: There is no economic condition or medical insurance restrictions, or due to the inability to tolerate its adverse reactions, can not take Sorafenib early treatment of HCC patients: 1) Aged 18-75 years old, male or female; 2) Patients with primary liver cancer diagnosed clinically or confirmed by histology/cytology according to 'Specifications for diagnosis and treatment of primary liver cancer' (Ministry of Health 2017), initial or postoperative recurrence, no indications for surgery and not included Other treatments including chemotherapy, radiotherapy, TACE, and ablation; 3) Karnofsky score = 70 points, ECOG PS score 0-2; 4) The expected life span is more than 3 months; 5) Child-pugh score rating A or B; 6) There is at least one measurable lesion with a lesion diameter greater than 15 cm; 7) Blood tests should meet the following criteria: WBC>4.0×109/L; 8) Contraindications without TACE; 9) Use of Solafini without economic conditions or limited medical coverage; 10) The patient voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have had other malignancies other than basic tumours in the past 5 years; 2. Child-pugh score grade C; 3. Patients with active bleeding or abnormal coagulation function; 4. Those with a history of deep vein thrombosis; 5. Any significant clinical and laboratory abnormalities that the investigator believes affect safety assessors, such as: uncontrolled active infections (>NCI-CTC AE v4.0 standard level 2), uncontrollable diabetes (>NCI- CTC AE v4.0 Level 2) Patients with hypertension who cannot be reduced to the following range with two or more antihypertensive drugs (systolic blood pressure NCI-CTC AE v4.0 Standard 2), etc.; 6. The patient has a mental disorder that affects the assessor; 7. Subjects and their partners are not willing to contraceptives during the trial and within 3 months after the end of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ECOG Score;Physical examination;Blood routine;Urine routine;Stool routine;Liver function test;Renal function test;Coagulation function test;Electrolyte;tumor marker;ECG;CT or MRI; | — |
Countries
China
Contacts
Public ContactJinglin Xia
Zhongshan Hospital, Fudan University
Outcome results
None listed