Hepatocellular carcinoma
Conditions
Interventions
donafeinib+HAIC+PD-1:Nil
Sponsors
The Fifth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary enrollment, the observed patients agreed to sign the informed consent form for participating in the experimental treatment and the observational study; 2. Age: 18-80 years old (including 80 years old), male and female; 3. Hepatocellular carcinoma patients who have been clinically diagnosed or clearly diagnosed by histology/cytology according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022); 4. Patients with potentially resectable liver cancer: intrahepatic lesions belong to stage IIb, IIIa liver cancer that is surgically resectable, oncology or biologically unresectable (that is, the tumor range is relatively limited) or stage Ia, Ib, IIa liver cancer (those who cannot achieve R0 resection); 5. Have not received systematic treatment. If the patients have received adjuvant chemotherapy after local treatment, the end of chemotherapy needs more than 12 months, and the patients with disease progression can also be enrolled; 6. The end time of the last intervention, radiotherapy and ablation treatment is>4 weeks; 7. Patients who have received hepatectomy in the past should be R0 resection, and tumor recurrence should be more than 24 months after surgery; 8. At least one evaluable lesion (RECIST 1.1 standard); 9. Expected survival time = 3 months; 10. The physical condition (PS) score of the Eastern Cancer Cooperation Group (ECOG) was 0-1; 11. Child-Pugh score = 7 points; 12. Be able to observe adverse events and curative effects cooperatively; 13. The function of main organs is normal, that is, they meet the following standards: Routine blood test (no blood transfusion and G-CSF used within 14 days before screening): 1) Hemoglobin = 90 g/L; 2) Absolute neutrophil count (ANC) = 1.5 × 109/L 3) Platelet count = 75 × 109/L Blood biochemical examination (no albumin was used within 14 days before screening): 1) Albumin = 28 g/L; 2) Total bilirubin = 2 × Upper limit of normal value (ULN); 3) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 5 × ULN 4) Alkaline phosphatase (ALP) = 5 × ULN 5) Creatinine = 1.5 × ULN Coagulation function: 1) International normalized ratio (INR) or prothrombin time (PT) = 1.5 × ULN 2) Activated partial thromboplastin time (APTT) = 1.5 × ULN
Exclusion criteria
Exclusion criteria: 1. Past or combined diseases: 1) Fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by histology/cytology; 2) Have a history of malignant tumors other than hepatocellular carcinoma, unless the following criteria are met: a) The patient has received possible curative treatment and there is no evidence of the disease within 5 years; b) The resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ were successfully received; 3) Diffuse tumor lesion; 4) Tumor vessel invasion occurs in one or more of the following cases: a) Involving superior mesenteric vein; b) Involving the inferior vena cava; 5) Have a history of hepatic encephalopathy, hepatorenal syndrome, or liver transplantation; Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage; 6) Central system metastasis; 7) Previous history of serious mental illness; 8) Have diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.); 9) Have been treated with HAIC in the past. 2. Previous or combined medication/treatment: 1) Previously received allogeneic stem cells or parenchymal organ transplantation; 2) He has previously received targeted treatment of anti-VEGF and/or VEGFR, RAF, MEK and other signal pathways such as sorafenib, rivatinib, and regofinib, or immunomodulators such as anti-PD-1, anti-PD-L1, and anti-CTLA-4; 3) Patients who have received other anti-tumor systemic treatment in the past, including traditional Chinese medicine with anti-tumor indications, less than 2 weeks after the completion of treatment and before the use of this study, or whose adverse events caused by previous treatment have not recovered to = CTCAE level 1; Toxic reactions of previous anticancer treatment did not include hair loss and grade 1/2 neurotoxicity caused by oxaliplatin; 3) At the same time, take drugs that may prolong QTc and/or induce torsade de pointe (Tdp) or affect drug metabolism; 4) Previous or current congenital or acquired immunodeficiency disease; 5) Systemic immunosuppressive drugs have been used within 2 weeks before enrollment, or systemic immunosuppressive drugs are expected to be required during the study, except for the following: a) Intranasal, inhalation, topical or local injection (such as intra-articular injection) of corticosteroids; b) The dose of prednisone or other systemic corticosteroids with equivalent effects is not more than 10 mg/day; c) Preventive use of corticosteroids for hypersensitivity; 3. Safety: 1) The patient is known or suspected to have a history of allergy to donafinil or similar drugs, or has a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or is allergic to the excipients of the study drug; 2) Active bleeding or abnormal coagulation function, bleeding tendency or undergoing thrombolytic, anticoagulant or antiplatelet therapy; 3) There have been thrombosis or thromboembolism events in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc; 4) There have been bleeding events from esophageal or gastric varices caused by portal hypertension within the past 6 months, or any life-threatening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Pathological response rate;Progress free survival;Overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactZhixian Hong
The Fifth Medical Center of PLA General Hospital
Outcome results
None listed