Hepatocellular carcinoma
Conditions
Interventions
Experimental group:donafenib+PD-1±HAIC for perioperative period (preoperative neoadjuvant + postoperative adjuvant)
Control group:donafenib+PD-1 for postoperative adjuvant
Sponsors
The General Hospital of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily participate and sign a written informed consent form; 2) Age 18-75 years (including 75 years), male and female; 3) Hepatocellular carcinoma patients diagnosed clinically according to the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2022 Edition)" or confirmed by pathological tissue/cytology; 4) At least one measurable lesion; 5) ECOG score 0-1 point; 6) Child-Pugh A level; 7) Patients who can be resected need to meet FLR/SLV>40% (patients with cirrhosis) or>30% (patients without cirrhosis), and have at least one of the following high-risk recurrence factors: ? Single tumor with diameter >6.5cm ? Number of tumors =3 ? Expected surgical margin less than 1cm ? Portal vein tumor thrombus (PVTT) involving secondary and above branches (Vp1, Vp2) ? Imaging confirmed incomplete tumor capsule ? Preoperative imaging or postoperative pathology confirmed the existence of satellite nodules ? Preoperative AFP>10000ng/ml 8) HBV DNA <104copies/ml (2000IU/ml). If HBV DNA =104copies/ml, antiviral treatment should be carried out first until HBV DNA drops below 104copies/ml before entering the study, and continue to take antiviral drugs and monitor liver function and HBV viral load; 9) Female patients with reproductive ability (referring to those who have not undergone menopause or surgical sterilization), the serum pregnancy test results within 7 days before the administration of the study drug must be negative; 10) Female or male patients with reproductive ability must take reliable contraceptive measures during the use of the study drug and within 60 days after the last dose; 11) Normal function of major organs
Exclusion criteria
Exclusion criteria: 1) Pathologically diagnosed as hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type; 2) Tumor invades the inferior vena cava and forms inferior vena cava tumor thrombus; 3) Portal vein trunk, first branch tumor thrombus (Vp3, Vp4); 4) Regional lymph node metastasis or extrahepatic metastasis; 5) Other malignant tumors within 5 years, unless the patient has received possible curative treatment and there is no evidence of the disease within 5 years. However, this time requirement (i.e., within 5 years) does not apply to patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ or other in situ carcinoma who have successfully undergone resection surgery; 6) History or current congenital or acquired immune deficiency disease; 7) Active or previously recorded autoimmune diseases or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, pituitary inflammation, hyperthyroidism or hypothyroidism, asthma requiring bronchodilators), patients with vitiligo or asthma that has been completely relieved in childhood and does not require any intervention after adulthood can be included; 8) History of severe mental illness; 9) Patients with diseases that affect the absorption, distribution, metabolism or elimination of study drugs (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.); Past or concurrent medication/treatment: 10) Previously received local treatment (including liver transplantation, TACE, HAIC, radiotherapy, etc., except for radical liver resection or ablation therapy), and patients with HCC who relapsed within 2 years after radical liver resection; 11) Previously received allogeneic stem cell or solid organ transplantation; 12) Previously received targeted drugs such as sorafenib, lenvatinib, regorafenib, apatinib, donafenib or immune checkpoint inhibitors such as anti-PD-1, anti-PD-L1 and anti-CTLA-4; 13) Received other systemic anti-tumor treatment including Chinese medicine with anti-tumor indications. Patients whose adverse events caused by preoperative treatment have not recovered to =CTCAE grade 1 before the study drug is used within 2 weeks after treatment completion are excluded; 14) Used systemic immunosuppressive drugs for treatment within 2 weeks before enrollment or expected to require systemic immunosuppressive drugs during the study period. However, the following situations are excluded: 15) Intranasal, inhalation, topical or local injection (such as intra-articular injection) of corticosteroids; 16) Dose does not exceed 10 mg/day prednisone or equivalent systemic corticosteroids; 17) Corticosteroids used for prophylaxis against hypersensitivity reactions; 18) Concurrent use of drugs that may prolong QTc and/or induce torsades de pointes (Tdp), or drugs that affect drug metabolism. Security: 19) The patient is known or suspected to have a history of allergy to Donaafinil or similar drugs, or has a history of Hypersensitivity to chimeric or humanized antibodies or fusion proteins, or is allergic to excipients of the study drug; 20) The presence of uncontrollable Hepatic encephalopathy, Hepatorenal syndrome, ascites, Pleural effusion or pericardial effusion; 21) Active bleeding or abnormal coagulation function, with a tendency to bleed or undergoing thromboly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year-recurrence-free rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Overall survival;Objective response rate;Disease control rate;Adverse event rate; | — |
Countries
China
Contacts
Public ContactMinggen Hu
The General Hospital of the People's Liberation Army
Outcome results
None listed