Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT03066557
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 - 75 years old;
2. Must be strictly in accordance with the "guidelines for primary liver cancer diagnosis and treatment" (2011 edition). According to clinical diagnosis standard or confirmed by histopathology or cytology, the patients with advanced primary liver cancer who can't be?removed surgically, and 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 treatment 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:
* Blood routine examination must meet: HB≥90 g/L, ANC≥1.5×10\^9/L, PLT≥60×10\^9/L;
* Biochemical examination should meet the following criteria: ALB ≥29 g/L, ALT and AST\<5xULN, TBIL ≤1.5xULN, creatinine≤1.5xULN (Only one of albumin and bilirubin can be 2 points in the rating of Child-Pugh);
9. The patients are willing to join in this study, and have signed the informed consent. The patients have good adherence, and are willing to cooperate with the follow-up.
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 abnormal (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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03066557
Study Brief:
Protocol Section:
NCT03066557