hepatocellular carcinoma
Conditions
Interventions
Observation group (Routine follow-up for liver cancer treatment is once a month within half a year, and every 3 months thereafter. If the patient is evaluated to be resectable during the follow-up per
Sponsors
Division of Biliary Surgery, Department of General Surgery, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Sign a written informed consent form before enrollment; (2)Age 18-70 years old; (3) Hepatocellular carcinoma (HCC) confirmed by histology or cytology; (4) Unresectable patients with BCLC stage C or B whose remnant liver volume is insufficient (the FLR is less than 30% in patients without liver disease, and less than 40% in patients with liver disease); (5) Have =1 measurable lesion (according to RECIST 1.1 standard); (6) Patients who have been treated with envolimab combined with lenvatinib within 1 month; (7)ECOG score: 0~1; (8)Child-Pugh score =7 points; (9) Have adequate organ function: a. Blood routine: WBC=3.0×10^9/L; ANC=1.5×10^9/L; PLT=100×10^9/L; HGB=90 g/L; b. Liver function: AST=2.5×ULN; ALT=2.5×ULN; TBIL=1.5×ULN; c. Renal function: Cr=1.5×ULN or CrCl =60 mL/min; d. Coagulation function: INR=1.5, APTT=1.5×ULN; e. There is no obvious abnormality in the electrocardiogram; (10) Estimated survival time = 3 months; (11) No childbearing or breastfeeding plans during the study treatment period and 6 months after the end of the study.
Exclusion criteria
Exclusion criteria: (1) The subject has suffered from other malignant tumors in the past or at the same time; (2) Those who plan to receive an organ transplant or have already undergone an organ transplant; (3) There is clear distant metastasis; (4) People with neuropsychiatric diseases, especially those with a history of mental illness such as depression, anxiety, mania, schizophrenia, or a family history of mental illness (especially those with a history of depression or tendency to depression); (5) It is known that the subject has been allergic to macromolecular protein preparations or applied pharmaceutical ingredients in the past; (6) Autoimmune diseases, including psoriasis, systemic lupus erythematosus, etc.; (7) Endocrine system diseases, including thyroid disease, diabetes, etc.; (8) Those with severe retinopathy or other serious eye diseases; (9) Have clinical symptoms or diseases that cannot be well controlled, such as: uncontrolled/poorly controlled hypertension, gastrointestinal bleeding or coagulation dysfunction, NYHA grade 2 or above heart failure, unstable angina, active/severe infection wait; (10) Those with organic disease or dysfunction of other important organs;(11) Those who are allergic to the study drug, or those who meet any of the contraindications in the instructions for the study drug; (12) Subjects with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA = 2000 IU/ml or = 104 copies/ml; hepatitis C reference: HCV RNA = 2000 IU/ml or = 104 copy number/ml; those who are lower than the above standards after nucleotide antiviral treatment can be enrolled); chronic hepatitis B virus carriers, HBV DNA < 104 IU/ml, During the trial, you must receive antiviral treatment at the same time before you can be enrolled; (13) Live vaccines may be administered less than 4 weeks before study medication or during the study period; (14) Known history of psychotropic substance abuse, alcoholism or drug abuse; (15) Patients who are deemed unable to participate/unsuitable for enrollment according to the researcher's assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion rate (percentage of operable patients); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;R0 removal rate;The 1-year recurrence-free survival rate;The 1-year overall survival rate;Adverse Events;The 1-year progression-free survival; | — |
Countries
China
Contacts
Public ContactLiping Chen
Division of Biliary Surgery, Department of General Surgery, West China Hospital, Sichuan University
Outcome results
None listed