Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:TACE+Camrelizumab +TKI drug
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-80 years; 2. Patients in strict accordance with the clinical diagnostic criteria of the code for diagnosis and treatment of primary liver cancer (2019 Edition): unresectable patients with advanced HCC confirmed by liver biopsy or histopathology or diagnostic imaging examination (CT or MRI); 3. Child Pugh liver function rating: Grade A or better grade B ( 80 in the first week; 7. Patients whose tumor condition meets one of the following conditions: (1) The first choice for clinical staging is stage IIB and IIIA. (2) Stage IB and IIA HCC can be resected, but can't or won't accept surgery or local ablation due to other reasons (such as advanced age, severe liver cirrhosis, etc.). (3) Some stage IIIB HCC patients with extrahepatic metastasis are expected to benefit from TACE treatment to control the growth of intrahepatic tumor. (4) In patients with massive liver cancer, the proportion of tumor in the whole liver is less than 70%. (5) Liver cancer whose main portal vein is not completely blocked, or whose portal vein has abundant compensatory collateral vessels, or whose portal vein can be recanalized by stent placement. (6) Portal hypertensive bleeding was caused by rupture of liver cancer and hepatic artery portal shunt. (7) High risk factors (including multiple tumors, combined with macroscopic / microscopic tumor thrombus, palliative resection, postoperative AFP and other tumor markers did not fall to the normal range, etc.) after hepatectomy, preventive TACE should be carried out in order to early detect and treat residual cancer or recurrence. (8) Liver cancer recurred after operation. (9) In order to reduce the tumor stage and create the opportunity for stage II resection or liver transplantation, the preoperative tumor reduction therapy should be performed. 8. Patients with at least one measurable lesion (according to the requirements of RECIST version 1.1, the long diameter of the measurable lesion is >= 10 mm or the short diameter of the enlarged lymph node is >= 15 mm); 9. Before TACE for the first time, patients with sufficient organ function should meet the following conditions: (1) Routine blood test (no blood transfusion and no use of hematopoiesis stimulating factor drugs within 14 days before screening): white blood cell count (WBC) >= 3.0 x 10^9 / L; absolute neutrophil count (ANC) >= 1.5 x 10^9 / L; platelet (PLT) >= 100 x 10^9 / L; hemoglobin (Hgb) >= 9.0 g / dl; (2) Liver function: aspartate aminotransferase (AST) = 200 ml / min; (4) Coagulation function: international normalized ratio (INR) 1.5 x ULN has no clinical or imaging confirmed pancreatitis can be included); amylase 1.5 x ULN has no clinical or imaging confirmed pancreatitis can be included
Exclusion criteria
Exclusion criteria: 1. Patients who have suffered from or are complicated with other malignant tumors, except for the following cases: (1) Cured early cancers with low recurrence rate, such as cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumor or early gastric cancer. (2) The patients who had been cured for more than 3 years before entering the study had no recurrence since then. 2. Past treatment history includes: (1) Systemic chemotherapy or targeted therapy for advanced liver cancer; (2) In the first 4 weeks, there were bleeding events in any part with grade >= CTCAE 3, unhealed wounds, ulcers or fractures, and invasive surgery was performed within 4 weeks; (3) Allogeneic transplantation, bone marrow transplantation or hematopoietic stem cell transplantation; (4) Have received anti-PD-1, anti-PD-L1, anti-CD137 or anti cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibodies (including ipilimumab or any other antibodies or drugs specifically targeting T cell costimulation or checkpoint pathway). 3. HBsAg positive and HBV DNA copy number higher than the upper limit of normal value (1000 copies / ml or 500 IU / ml) in the laboratory of the research center; known history of HIV positive or known acquired immune deficiency syndrome (AIDS); 4. Patients with hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), grade I coronary heart disease, grade I arrhythmia (including QTc interval prolongation > 450 ms for men and > 470 MS for women) and grade I cardiac insufficiency; patients with positive urine protein; patients with hypertension and hypertension who can not be reduced to normal range after antihypertensive drug treatment; 5. Patients with multiple factors affecting oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 6. Patients with known allergy to drugs or excipients; 7. Patients with hepatocellular carcinoma and portal vein tumor thrombus (PVTT) type IV; 8. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of pulmonary function; 9. Patients with definite bleeding tendency include the following situations: Patients with local active ulcer lesions and occult blood in stool (+ +); patients with history of black stool and hematemesis within 2 months; patients with history of bleeding in stool (+ +); 10. Patients with active, known or suspected autoimmune diseases. Patients with vitiligo, type I diabetes, residual hypothyroidism due to autoimmune thyroiditis requiring hormone replacement therapy only, or those who are not expected to relapse in the absence of external stimulation can be enrolled; 11. Patients who used corticosteroids (> 10 mg / day prednisone or equivalent) or other immunosuppressants within 14 days before the first dose of study drug. Inhaled or topical steroids and adrenal replacement steroids are permitted in the absence of active autoimmune diseases; 12. Patients with uncontrolled clinical cardiac symptoms or diseases, such as: (1) New York Heart Association (NYHA) grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 24 weeks; (4) Supraventricular or ventricular arrhythmias with clinical significance need treatment or intervention; 13. Pregnant or lactating women; patients who may be pregnant or plan to b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival rate (PFS);Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Duration of responce;Time to Progression; | — |
Countries
China
Contacts
Public ContactSong Jinlong
Shandong Cancer Hospital
Outcome results
None listed