Hepatocellular Carcinoma
Conditions
Sponsors
Zhongda Hospital,Affiliated to Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 70 years old; 2. According to the "guidelines for primary liver cancer diagnosis and treatment" (2011 edition) clinical diagnosis standard or confirmed by histopathology or cytology, the patients was diagnosed with hepatocellular carcinomawith who can't be removed surgically, or can't accept palliative surgery or radiation therapy, and have at least one measurable lesions;The biggest tumor 10 cm or less; 3. Refuse the treatmeant of sorafenib; 4. The Child - Pugh( liver function grade): grade A or better grade of B (=7 points); 5. BCLC stage for B or C; 6. Within 1 week before into the study,ECOG PS0-1; 7. The expected lifetime of patients should be equal to or more than 12 weeks; 8. The main viscera function of patients must be normal, and should meet the following requirements: (1) Blood routine examination must meet: HB=90 g/L, ANC=1.5×10^9/L, PLT=60×10^9/L; (2) Biochemical examination should meet the following criteria: ALB =29 g/L, ALT and ALT <200U/L and AST<200U/L, creatinine=159µmoI/L (Only one of albumin and bilirubin can be 2 points in the rating of Child-Pugh); 9. The patient is willing to join in this study, and have signed the informed consent. The patient have good adherence, and is willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients have received radiotherapy or chemotherapy within four weeks before the study; 2. In the past (within 5 years) or at the same time,patients were diagnosed with other malignant tumor which have not been cured. As for skin basal cell carcinoma and cervical carcinoma in situ,they can be excepted; 3. Patients who are diagnosed with hypertension which cant be reduced to normal range via antihypertensive drug treatment(systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg); 4. Patients who are diagnosed with II or higher level of myocardial ischemia, myocardial infarction, uncontrolled arrhythmia(including QTc interval prolongation men> 450 ms, female> 470 ms); 5. There are many factors which can influence the oral drug absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction, which can significantly affect the drug taking and absorption); 6. Within 6 months in the past,the patients have a history of gastrointestinal bleeding or a gastrointestinal bleeding tendency, for example,there is a risk of bleeding of esophageal varicose veins, local active ulcerative lesions, defecate occult blood = (+ +)(+) shall not be admitted into the study; 7. within 28 days before being admitted into the study, there is abdominal fistula, gastrointestinal perforation or abdominal abscess; 8. Blood coagulation function is abnormol (INR>1.5 or PT> ULN+4s), and the patients are able to be faced with a bleeding tendency or being treated with thrombolysis and anticoagulation; 9. Has been diagnosed with ?the central nervous system metastases or the brain metastases has been known; 10. There are past medical history or history of present illness of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia, pulmonary function test suggests there is objective evidence of severely damaged lung function; 11. Urine routine inspection suggests that the urine protein =++;24 hours urine protein examination>1.0 g; 12. Within 7 days before being admitted into the study,patients have received a potent CYP3A4 inhibitor treatment, or within 12 days before being admitted into the study,patients have received potent CYP3A4 inducers treatment; 13. Pregnant or lactating women;Patients with fertility are unwilling or unable to take effective contraceptive measures; 14. With a mental illness, or has a history of psychiatric drugs abuse; 15. patients with HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to progression;Overall survival;Disease Control Rate;Objective response rate;The quality of life; | — |
Countries
China
Contacts
Public ContactTeng Gaojun
Zhongda Hospital, Affiliated to Southeast University
Outcome results
None listed