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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT03520257
Eligibility Criteria:
Inclusion Criteria:
1. Age: ≥18 years old;
2. An unresectable HCC patient who is in strict compliance with the criteria for diagnosis and treatment of primary liver cancer (2011 edition) or who has been diagnosed by pathological or cytological examination and has at least one measurable lesion;
3. Child-Pugh Liver Function Rating: Grade A or better Grade B (≤ 7 points);
4. Cheng's type I and type II (imaging evaluation of the tumor portal vein tumors did not reach the contralateral portal vein branch, and embolization does not exceed 50% of the portal vein diameter) PVTT BCLC-C patients;
5. Clinical evaluation cannot tolerate radical surgical resection;
6. The tumor is confined to the hepatic liver;
7. The first patient who had not received any anti-cancer comprehensive treatment before;
8. ECOG PS score: 0-1 points;
9. The expected survival period is ≥ 3 months;
10. The normal function of the major organs is the following:
* Blood tests:
1. HGB≥90 g/L;
2. Neutrophil absolute count (ANC) ≥ 1.5 × 109/L;
3. PLT≥60×109/L;
* Biochemical tests:
1. ALB ≥ 29 g/L;
2. ALT and AST \<2.5ULN;
3. TBIL ≤ 2ULN;
4. Creatinine ≤1.5ULN; (Child-Pugh can only have 2 points for both albumin and bilirubin)
11. Subjects voluntarily joined the study and signed informed consent. Good compliance and follow-up.
Exclusion Criteria:
1. Pregnancy or breast-feeding women, or those who are unwilling or unable to take effective contraceptive measures if they have fertility, women who are of child-bearing age will have a pregnancy test (+) within 7 days before enrollment;
2. Participated in other drug clinical trials within 8 weeks before the start of the study;
3. History of other malignancies in the past 5 years;
4. Ascites with clinical symptoms, which require therapeutic paracentesis or drainage;
5. People with high blood pressure who are unable to fall within the normal range after treatment with antihypertensive drugs (systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg);
6. Arrhythmia with grade II or higher myocardial ischemia or myocardial infarction and poor control;
7. In accordance with NYHA criteria III-IV heart failure or cardiac ultrasound examination: LVEF (left ventricular ejection fraction) \<50%;
8. No other serious heart, lung, brain, kidney dysfunction;
9. Has a variety of factors that affect oral medications (eg, inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affect drug use and absorption);
10. In the past 6 months, there was a history of digestive tract bleeding or a clear tendency to gastrointestinal bleeding. For example, esophageal varices, local active ulcer lesions, fecal occult blood ≥ (++) with risk of bleeding may not be included in the group; If fecal occult blood (+) requires gastroscopy;
11. Incidental arterial/venous thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis, and pulmonary embolism within the first 6 months of study initiation;
12. Coagulation abnormalities (INR\> 1.5 or prothrombin time (PT)\> ULN + 4 seconds) with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
13. Urinary cues suggest that urinary protein ≥ ++ and confirm 24-hour urinary protein quantification\> 1.0 g;
14. Those who have a history of abuse of psychotropic substances and are unable to get rid of or have a history of mental disorders;
15. Existence of immune diseases or HIV infection;
16. The investigator judges other situations that may affect the conduct of clinical studies and the findings of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03520257
Study Brief:
Protocol Section:
NCT03520257