Hepatocellular Carcinoma
Conditions
Interventions
Medication group started before TACE:TACE&Apatinib Mesylate& Camrelizumab (PD-1)
Medication group started after TACE:TACE&Apatinib Mesylate& Camrelizumab (PD-1)
Sponsors
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following options simultaneously: 1. Patients who meet the criteria of pathological diagnosis, aged 18-75, both male and female; 2. BCLC stage is stage C, with at least one measurable lesion; 3. Patients with child Pugh score a-b7; 4. ECoG score = 50 *10^9 / L, leukocytes >= 3.0 * 10^9 / L, neutrophils >= 1.5 * 10^9 / L, Hgb >= 90 g / L (the standard of blood routine test can be reduced in case of hypersplenism); Coagulation: prothrombin activity >= 50%, international standardized ratio = 30ml / min; 6. Patients with an estimated survival time of at least 12 weeks; 7. Patients with active hepatitis B virus (HBV) infection: HBV DNA < 2000 IU / ml (if the research center only has the copy / ml detection unit, it must be < 104) Copy / ml) and received antiviral treatment at least 14 days before the start of the study, and received antiviral treatment during the study; hepatitis C virus (HCV) RNA positive patients: HCV-RNA < 103 / ml, must receive antiviral treatment according to the local standard treatment guidelines, and the liver function is within the level 1 increase of CTCAE 8. Pregnant women of childbearing age (generally 15-49 years old) shall have negative pregnancy test (serum or urine) within 3 days before entering the group, and they shall voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; for men, they shall be sterilized by operation or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug. 9. The subjects voluntarily participated in the study, signed the informed consent, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: Any of the following conditions shall not be included in this test: 1. Patients with a history of severe esophageal varices or ruptured bleeding; 2. Patients who participated in other clinical trials / drug trials within 3 months before enrollment; 3. Patients with severe jaundice and massive ascites; 4. Patients with extremely poor or cachexia; 5. Patients with severe multiple organ dysfunction; 6. Patients with active infection; 7. Patients who have previously received embolization, radiotherapy and other ablation treatment; the distance between molecular targeted treatment (including oral targeted drugs for other clinical trials) and the first study medication is less than 5 drug half lives, or the adverse events (except hair loss) caused by previous treatment have not recovered to 450 ms in men and > 470 MS in women) MS, QTCF interval calculated by fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 17. The patients with hypertension can not get good control (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg) after treatment with antihypertensive drugs; 18. Patients with abnormal coagulation (INR > 1.5 or APTT > 1.5 * ULN) have bleeding tendency or are undergoing thrombolysis or anticoagulation treatment; 19. Patients with known hereditary or acquired bleeding and thrombotic tendencies, such as hemophilia, coagulation dysfunction, etc; 20. Patients with obvious cough blood or hemoptysis of half teaspoon (2.5ml) or more per day before entering the study; 21. Patients who had si
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mOS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 months OS rate;12 months OS rate;PFS;ORR;DCR;Safety index; | — |
Countries
China
Contacts
Public ContactHuaming Wang
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
Outcome results
None listed