HCC
Conditions
Interventions
experimental group:After 1-2 doses of TACE combined with Carrilizumab plus apatinib mesylate (2-4 cycles), the patients evaluated as PR/SD were treated with microwave ablation for lesions with residua
Sponsors
Eastern Theater General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Participants must be at least 18 years old at the time of screening. 2) Confirmed HCC (by imaging or histopathological examination based on biopsy specimens and/or surgery). 3) No evidence of extrahepatic metastasis was found on any of the available images. 4) It is not suitable for radical surgery or transplantation or radical ablation. 5) Liver lesions meet the maximum tumor diameter + number =12, no contraindications for TACE treatment. 6) Child-Pugh grade A (i.e. score of 5 to 6), or B7. 7) WHO or ECOG physical status score of 0 or 1 with no deterioration at baseline or 2 weeks prior to the first dosing date. 8) At least one measurable intrahepatic target is suitable for repeat evaluation according to the following mRECIST criteria: Hepatic lesions on contrast-enhanced CT or MRI scans show typical HCC features, namely rapid arterial intensification with rapid portal venous decline or late venous decline; The active non-necrotic portion (enhanced by contrast media during arterial phase) can be accurately measured at baseline with a maximum diameter =10 mm. 9) Subjects with active HBV infection who are positive for hepatitis B virus surface antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBCAB), If HBV deoxyribonucleic acid (DNA) can be detected (=10 IU/mL or higher than the detection limit specified by local laboratory standards), antiviral therapy must be performed in accordance with institutional treatment standards. HBV antiviral therapy must be initiated prior to randomization, and participants must maintain antiviral therapy during the study period and for 6 months after the last administration of the study drug. Before starting the study intervention, subjects must show evidence of HBV stabilization or signs of a viral response (e.g., reduced HBV DNA levels). Prior to randomization, subjects who tested positive for HBsAg or anti-hepatitis B core (HBc) and were undetectable for HBV DNA (detectable for HBV DNA) must begin antiviral therapy and maintain antiviral therapy during the study period and for 6 months after the last administration of the study drug. 10) Subjects with active HCV infection (manifested by the presence of detectable HCV ribonucleic acid [RNA] or anti-HCV antibody [anti-HCV]) must be managed during the study period and within 6 months after the last dosing of the study therapy in accordance with local institutional guidelines. 11) Normal organ and bone marrow function was detected within 72 hours prior to randomization, as defined below: - Hemoglobin = 9.0 g/dL. - Absolute neutrophil count =1.0×109 /L. - Platelet count =75×109 /L. - Total bilirubin (TBIL) =2.0 x Upper limit of normal (ULN). - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =5 x ULN - Albumin =2.8 g/dL. - The international standardized ratio =1.6. - Urine test strip reading of urinary protein 2+ or lower. Subjects with urinary protein >2+ or higher urine test strip readings will undergo a 24-hour urine collection to quantitatively assess proteinuria. Participants with urinary protein =1 g/24 hours were not eligible for study participation. - Calculated creatinine clearance =30 mL/min as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine CrCL. Male: CrCL= (mL/min) Weight (kg) × (140 -- age) 72× serum creatinine (mg/dL) Female: CrCL= (mL/min) weight (kg) × (140 -- age) × 0.85 72× serum creatinine (mg/dL) 12) Minimum life expectancy is at least 12 weeks. 13) Female subjects must be 1 year pos
Exclusion criteria
Exclusion criteria: 1) According to the researchers, there was evidence of any disease(e.g. severe or uncontrolled systemic disease), This includes active bleeding disease, active systemic infection (other than HBV infection or HCV infection), active interstitial lung disease (ILD)/non-infectious pneumonia, severe chronic gastrointestinal disease associated with diarrhea, mental illness/social condition, or a history of allotransplantation, Moreover, the researchers believed that these factors were not conducive to the participants' participation in the study or might affect the protocol compliance. 2) Uncontrolled arterial hypertension is defined as systolic blood pressure =150 mm Hg or diastolic blood pressure =90 mm Hg or other hypertensive cardiovascular complications despite standard medical management. 3) Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulations, or prior major bowel resection that would prevent adequate absorption, distribution, metabolism, or excretion of apatinib. 4) A history of other primary malignancies, except: 1) a malignancy that has been treated radically or has a low risk of potential recurrence, and no known active disease for =5 years prior to the first administration of the study intervention; 2) Malignancies that recur or are not clinically significant before the first administration of the study intervention (further pending may be considered for further discussion with the study physician prior to randomization). 5) Persistent toxicity from prior anticancer therapy (General Terminology Standard for Adverse Events [CTCAE]> Grade 2); Except for alopecia and vitiligo toxicity. 6) Active or previously documented autoimmune diseases or inflammatory diseases (including inflammatory bowel disease [e.g., Colitis or Crohn's disease], diverticulitis [other than diverticulitis], systemic lupus erythematosus, sarcoidosis, granulomatous vasculitis, Gray's disease, rheumatoid arthritis, pituitaritis, uveitis, etc., autoimmune pulmonary inflammation and autoimmune myocarditis). Here are the exceptions to this standard: Subjects with vitiligo or hair loss. - Subjects with hypothyroidism who are stable after hormone replacement therapy (e.g., after Hashimoto's thyroiditis). - Any chronic skin disease subject who does not require systemic treatment. Subjects who have not had active disease in the past 5 years may be enrolled, but only after consulting the clinical director of the study. - Subjects who can control celiac disease with diet alone. 7) History of pial meningeal cancer. 8) Co-infection with HBV and hepatitis D virus (HDV). HBV infection means the presence of HBsAg and/or anti-HBCAB and detectable HBV DNA=10 IU/mL or higher than the detection limits specified by local laboratory standards; Hdv-positive infection refers to the presence of anti-HDV antibodies.) 9) A known positive human immunodeficiency virus (HIV) test result (positive HIV 1/2 antibody) or a positive test result for tuberculosis infection (clinical evaluation may include clinical history, physical examination and imaging findings, or TB testing in accordance with local practice). 10) A history of congestive heart failure that is symptomatic or requiring treatment (CTCAE grade 3), unstable angina pectoris, uncontrolled arrhythmias (multigenic preventricular systole, digitya, triitya, ventricular tachycardia), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic persistent ventricular tachy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival ;objective response rate;Disease Control Rate;Recurrence free survival;2y-Overall Survival ;1y-Overall Survival ; | — |
Countries
China
Contacts
Public ContactFeng Wang
Nanjing General Hospital of Nanjing Military Region
Outcome results
None listed