Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:Apatinib +Camrelizumab+HAIC
Sponsors
Cancer Hospital Affiliated to Shandong First Medical University(Shandong Cancer Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects with hepatocellular carcinoma diagnosed or pathologically diagnosed according to the clinical diagnostic criteria of the diagnosis and treatment of primary liver cancer (2019 edition); 2. Subjects whose BCLC stage is B-C; 3. Subjects whose Child-Pugh is grade A; 4. Subjects whose the ECOG score is 0-1; 5. Subjects without extrahepatic metastases, no diffuse multiple tumors throughout the liver; 6. According to the researchers assessment, subjects with hepatocellular carcinoma who do not have the conditions for radical resection, but are expected to achieve radical resection after conversion therapy, including but not limited to one of the following situations: 1) There are less than 3 tumors and mainly concentrated on the side of the liver; 2) Imaging proved to be combined with portal vein tumor thrombus (PVTT); 3) The investigator believes that other situations where radical resection may be achieved through conversion therapy. 7. Subjects whose estimated survival period is more than 3 months; 8. Subjects with at least one measurable lesion (according to the RECIST 1.1 standard, the long diameter of the CT scan of tumor lesions is >= 10mm, and the short diameter of CT scan of lymph node lesions is >= 15mm); 9. Newly treated subjects who have not undergone any local or systemic treatment for tumors in the past, and hepatocellular carcinoma patients who have undergone radical resection before recurrence after 2 years can be included; 10. Subjects Routine laboratory tests (blood routine, liver and kidney function, coagulation function, etc.) have no significant abnormalities 11. Subjects with potential for childbirth need to use a medically approved contraceptive method (such as intrauterine device, contraceptive pill or condom) during the study treatment period and within 1 month after the end of the study treatment period; and The serum or urine HCG test within 72 hours before study entry must be negative, and it must be a non-lactating period; 12. Aged 18-80 years; 13. Subjects participated in the study voluntarily, without mental illness or other mental symptoms, with full civil capacity, signed informed consent, good compliance, and able to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed by histology/cytology with fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 2. A history of hepatic encephalopathy, or a history of liver transplantation; 3. A history of allergies to test drugs: Camrelizumab and any component of other drugs; 4. The subject's refractory pleural or pericardial effusion is poorly controlled; 5. Previously received anti-PD-1 or PD-L1 or CTLA-4 or Car-T immunotherapy; 6. Except for history of interstitial lung disease (radiation pneumonia that has not been treated with hormones), history of non-infectious pneumonia; 7. The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , Nephritis, hyperthyroidism, reduced thyroid function; subjects suffering from vitiligo or asthma in childhood has completely resolved, and no intervention after adults can be included; subjects with asthma requiring bronchodilators for medical intervention can not be included ); 8. The subject is using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose > 10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use; 9. Severe infections (CTCAE> level 2) occurred 4 weeks before the first use of the study drug; 10. The subject has experienced acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction, acute coronary syndrome, etc. and the cardiovascular clinical symptoms or diseases within one month are not well controlled; 11. According to NYHA standards, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination reveals that the left ventricular ejection fraction (LVEF) is less than 50%; 12. Patients with a clear gastrointestinal bleeding tendency, including the following conditions: local active ulcer lesions, and fecal occult blood {(++) can not be included in the group}; patients with a history of melena and hematemesis within 2 months; 13. Abnormal blood coagulation function (INR > 1.5APTT > 1.5ULN), with bleeding tendency; 14. Long-term unhealed wounds or fractures; major surgical operations or severe traumatic injuries, fractures or ulcers occurred within 4 weeks; 15.Subjects with congenital or acquired immune deficiencies (such as HIV-infected persons), or active hepatitis (hepatitis B reference: HBV-DNA detection value exceeds 2000 IU/ml) need to be excluded; if the patient has active hepatitis B virus (HBV) Infection: HBV-deoxyribonucleic acid (DNA) <2000 IU/mL, and received anti-HBV therapy for at least 14 days before randomization and is willing to receive antiviral therapy throughout the study period (recommended nucleoside analogs such as Entecavir or Tenofov ir Disoprox, etc.) can be included in the study. 16. Patients with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; 17. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 18. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate;Surgical conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR;Objective response rate (ORR);The disease control rate (DCR);Duration of response (DOR);The progression-free survival time (PFS);The overall survival time (OS);The overall survival rate of 1-year and 2-year(1-year and 2-year OSR);QoL;drug safety; | — |
Countries
China
Contacts
Public ContactLei Zhao
Cancer Hospital Affiliated to Shandong First Medical University(Shandong Cancer Hospital)
Outcome results
None listed