HCC
Conditions
Interventions
experimental group:HAIC+regorafenib+camrelizumab
Sponsors
Department of Hepatobiliary Surgery, Xinqiao Hospital, Army Medical University, Chongqing 400037, China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Clinically diagnosed as hepatocellular carcinoma according to the 2019 edition of the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer; 2.Patients with B-C liver cancer according to Barcelona staging (BCLC); 3.Patients are not suitable or unable to undergo surgical treatment or local ablation; 4.Progression of disease after first-line treatment with targeted drugs (TKIs); 5.Child-Pugh Liver Function Rating: Grade A or good Grade B ( = 18 years old, = 3 months; 10.No previous HAIC/ radiofrequency ablation; 11.Normal function of major organs, that is, meeting the following criteria: (1) Routine blood test :(no blood transfusion, no G-CSF, no drug correction within 14 days before screening) Hb >= 90 G /L;The ANC acuity 1.5 x 10^9 / L;PLT 60 x 10^9 / L or higher; (2) Biochemical tests :(no ALB within 14 days) ALT and AST<5 x ULN; TBIL 2 x ULN or less; Creatinine 1.5 x ULN or less; 12.Subjects volunteered to participate in this study, signed the informed consent, and showed good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1.Known hepatobiliary cell carcinoma, mixed cell carcinoma and fiberplate lamellar cell carcinoma;Previous (within 5 years) or co-existing uncured malignancies, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 2.Great vessel invasion or extrahepatic metastasis; 3.Previous allergy to any component of carrilizumab and regofinib; 4.Patients who are preparing for liver transplantation (except those who have previously undergone liver transplantation); 5.Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices bleeding; 6.Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure BBB> mmHg); 7.With above level II myocardial ischemia or poor control of myocardial infarction, arrhythmia; 8.There are multiple factors that affect the oral administration of the drug (such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect the administration and absorption of the drug); 9.A history of gastrointestinal bleeding or a definite tendency of gastrointestinal bleeding within the previous 6 months, such as esophageal varicose veins with bleeding risk, local active ulcer lesions, or fecal occult blood >= (++) were not included in the group; 10.Has a bleeding tendency or is receiving thrombolytic or anticoagulant therapy; 11.Patients with CNS metastases or known brain metastases; 12.Routine urine showed urinary protein >= ++ or confirmed 24-hour urinary protein quantitative > 1.0 g; 13.Pregnant or lactating women;Fertile patients unwilling or unable to take effective contraceptive measures; 14.Combination of HIV infected patients; 15.Has received any of the following treatment: (1)Received any investigational drug within 4 weeks prior to the first use of the investigational drug; (2)Enrol in another clinical study at the same time, unless it is an observational (non-interventional) bedside study or an interventional clinical study follow up; (3)Subjects requiring systematic treatment with corticosteroids (> equivalent dose of 10 mg prednisone per day) or other immunosuppressant within 2 weeks prior to the first use of the study drug, except for cutaneous steroids for local inflammation and for the prevention of allergy and nausea and vomiting.Other special circumstances, need to communicate with the sponsor.In the absence of active autoimmune disease, inhalation or topical administration of corticosteroid and the therapeutic dose of > 10 mg/ day prednisone is allowed for corticosteroid replacement; (4)Those who have received an anti-tumor vaccine or have received a live vaccine within 4 weeks prior to the first administration of the investigational drug; (5)Major surgery or severe trauma within 4 weeks prior to the first use of the study drug; 16.Previous antitumor therapy toxicity does not recover to grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc., requiring hospitalization;Baseline chest imaging examination suggests active pulmonary inflammation, signs and symptoms of infection within 2 weeks prior to first use of the st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Adverse events;Disease progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZheng Lu
Department of Hepatobiliary Surgery, Xinqiao Hospital, Army Medical University
Outcome results
None listed