hepatocelullar carcinoma
Conditions
Interventions
Group A:ATRA+XELOX
Group B:Placebo+XELOX
Sponsors
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily joined the study and signed informed consent; 2. Male and female, ages 20-70 years; 3. Clinically or pathologically diagnosed hepatocellular carcinoma, CT or MRI diagnosed recurrence after Liver transplantation; 4.Serological examination meets at least one of the following requirements: 1) AFP>=400ng/mL; 2) AFP-L3 accounted for the proportion of total AFP, AFP-L3%>=10%; 3) DCP>=40.0ng/mL; 5. Child-Pugh Class A or B; 6. ECOG performance status Grade 1 or less; 7. The expected survival was greater than 12 weeks; 8. The functions of vital organs meet the following requirements(No blood components, cytokines, or other corrective therapy should be used within 14 days before the first administration): 1) Hemoglobin>=90 g/L; 2) neutrophil count>=1.5*10^9/L; 3) platelet count>=60*10^9/L; 4) serum albumin>=30g/l; 5) Total bilirubin1000 copies/ml, oral antiviral drugs should be recommended at least 1 week before chemotherapy; 10. For non-surgical sterilization or reproductive age of female patients, a medically approved method of contraception is required during the study and within 3 months after treatment. For non-surgical sterilization or reproductive age of female patients must be negative for serum or urine HCG within 72 hours prior to study enrollment; And it must be non-lactation.
Exclusion criteria
Exclusion criteria: 1. HCC patients who had been treated with ATRA or XELOX regimen; 2. Liver tumor burden was greater than 50% of the total liver volume, and with defined brain metastases; 3. Ascites with clinical symptoms requiring puncture, continuous drainage, or receiving ascites drainage for the past 3 months, except for those who showed a small amount of ascites by imaging,but without linicalptoms; 4. Have heart clinical symptoms or disease that are not well controlled: (1) heart failure above grade 2, unstable angina pectoris; (2) myocardial infarction occurred within 1 year; (3) supraventricular or ventricular arrhythmia needs treatment or intervention; 5. Abnormal coagulation function (INR>2.0, PT>16s), with bleeding tendency or being treated with thrombolysis or anticoagulation, allowing preventive use of low-dose aspirin, low molecular heparin, etc; 6. Bleeding symptoms with significant clinical significance or a clear tendency to bleeding were observed within 3 months; 7. Known hereditary or acquired bleeding and tendency to thrombosis such as hemophilia patients, coagulopathy, thrombocytopenia and so on; 8. Urinary routine suggested that urinary protein was greater than ++ and 24-hour urinary protein was confirmed to be>1.0g. 9. Patients who had received radiotherapy, TACE, and hormone therapy within 4 weeks; Patients who did not recover to level 1 of CTCAE due to adverse events (except hair loss) in previous treatment;Patients who had received molecular targeted drugs is not affected, but should be avoided; 10. Patients with active infection; 11. Patients with HIV, HCV or syphilis; 12. The patient had other malignant tumors within the previous 3 years or at the same time; 13. Patients with chronic headaches or migraines who cannot be relieved by medication; 14. Patients with contraindications to retinoic acid; 15. Other reasons were not considered appropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DoR;TTR;DCR;ORR; | — |
Countries
China
Contacts
Public ContactHe Kang
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed