HCC
Conditions
Interventions
experimental group:HAIC+Regorafenib+PD-1 inhibitor
control group:Regorafenib+PD-1 inhibitor
Sponsors
Department of Hepatobiliary Surgery, Xinqiao Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. According to the 2019 version of "Primary Liver Cancer Diagnosis and Treatment Standards" clinically diagnosed as hepatocellular carcinoma; 2. According to the Barcelona staging (BCLC) for liver cancer patients of stage B-C; 3. The patient is not suitable or unable to undergo surgical treatment or local ablation; 4. First-line treatment with targeted drugs (TKIs) has disease progression; 5. Child-Pugh liver function rating: Grade A or better Grade B (=1 measurable tumor lesion (mRECIST 1.1 standard) 9. Estimated survival time >= 3 months; 10. Have not received HAIC/radio frequency ablation treatment in the past; 11. The main organs are functioning normally, that is, they meet the following standards: (1) Routine blood examination: (no blood transfusion, no G-CSF, no medication correction within 14 days before screening) HB>=90 g/L; ANC>=1.5x10^9/L; PLT>=60x10^ 9/L; (2) Biochemical examination: (no ALB infusion within 14 days) ALT and AST<5xULN; TBIL <=2xULN; creatinine <=1.5xULN; 12. The subject voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Known liver cholangiocarcinoma, mixed cell carcinoma and fibrolamellar cell carcinoma; previously (within 5 years) or at the same time suffering from other uncured malignancies, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. Invasion of large blood vessels or extrahepatic metastasis; 3. A history of allergies to any component of Carrelizumab and Regorafenib; 4. Patients who are going to undergo liver transplantation (except those who have undergone liver transplantation in the past); 5. Uncontrollable ascites, hepatic encephalopathy or bleeding from esophageal and gastric varices; 6. Suffer from high blood pressure and cannot fall within the normal range after treatment with antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 7. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, which obviously affect the administration and absorption of drugs); 8. Patients with central nervous system metastases or known brain metastases; 9. Urine routine shows urine protein >= ++ or confirmed 24-hour urine protein quantitative > 1.0 g; 10. Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures; 11. Combined with HIV-infected patients; 12. Have received any of the following treatments: (1) Have received any investigational drug within 4 weeks before using the investigational drug for the first time; (2) Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; (3) Subjects who need to be given corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies, nausea, Use of corticosteroids for vomiting. Other special circumstances require communication with the sponsor. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal corticosteroids with a dose > 10 mg/day of prednisone are allowed to be substituted; (4) Those who have received anti-tumor vaccines or have received live vaccines within 4 weeks before the first administration of the study drug; (5) Have undergone major surgery or suffered serious trauma within 4 weeks before using the study drug for the first time; 13. The toxicity of the previous anti-tumor treatment has not recovered to level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infectious comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest the presence of active lungs Inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics); 15. Active autoimmune diseases, autoimmune diseases History 16. A history of interstitial lung disease (excluding radiation pneumonia that has not been treated with hormones) and a history of non-infectious pneumonia; 17. Patients with active pulmonar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Disease progression free survival;Overall survival;Adverse events; | — |
Countries
china
Contacts
Public ContactZheng Lu
Department of Hepatobiliary Surgery, Xinqiao Hospital, Army Medical University
Outcome results
None listed