Hepatocellular Carcinoma
Conditions
Interventions
ESTTI group:Portal vein 125I particle chain implantation+portal vein stenting+transcatheter arterial intervention+targeted therapy+immunotherapy
TTI group:transcatheter arterial intervention+targeted therapy+immunotherapy
Sponsors
Mengchao Hepatobiliary Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The diagnosis of hepatocellular carcinoma (HCC) was confirmed in accordance with the Guidelines for the Management of Primary Liver Cancer 2022 Edition. 2. Additionally, the patient presented with type III-IV portal vein tumor thrombosis (PVTT) formation. 3. Furthermore, the presence of at least one measurable HCC lesion was confirmed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST 1.1 criteria. 4. Prior to the initiation of Transarterial Interventional Therapy (TAIT), patients were required to have a Child-Pugh score of grade A or B = 7 within 7 days. 5. The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score was also assessed within 7 days prior to the first TAIT treatment, with patients falling within the range of 0-2. 6. All participants were expected to have a life expectancy of more than 3 months. 7. Male or female individuals, aged = 18 years and = 75 years at the time of providing informed consent. 8. Informed consent, in written form, was obtained from each participant (or their legal representative, if applicable) prior to their participation in the study. 9. Participants were required to demonstrate adequate organ function as defined below. Specimens for assessment were collected within 7 days before the initiation of the first TAIT treatment. 9.1 Routine blood tests (excluding hemoglobin levels that have been transfused or medically corrected within the past 2 weeks, and those receiving granulocyte colony-stimulating factor [G-CSF]) revealed the following criteria: absolute neutrophil count (ANC) = 1.5 x 109/L, platelets = 75 x 109/L, and hemoglobin = 90 g/L. 9.2 Renal function assessment was conducted using the following criteria: serum creatinine = 1.5 times the upper limit of normal (ULN) and creatinine clearance (CrCl) = 50 ml/min. CrCl was calculated using the Cockcroft-Gault formula as follows: For males, creatinine clearance = [(140 - age) x body weight)]/ (72 x blood Cr). For females, creatinine clearance = [(140 - age) x body weight)]/ (72 x blood Cr) x 0.85. Body weight was measured in kilograms, and blood Cr was measured in milligrams per milliliter. 9.3 Liver function assessment included the following criteria: total bilirubin = 51 µmol/L, aspartate transaminase (AST) and alanine transaminase (ALT) = 5 times the ULN, amylase and lipase = 1.5 times the ULN, and serum albumin = 30 g/L. 9.4 Coagulation function was evaluated based on the following criteria: international normalized ratio (INR) = 2.0 or prothrombin time (PT) = 6 s above the range observed in normal controls.
Exclusion criteria
Exclusion criteria: 1. Patients with a recent history of bleeding from ruptured oesophageal or gastric varices within the past 6 months are excluded from the study. 2. Individuals who have a bleeding or thrombotic disorder, or those who are taking factor X inhibitors or anticoagulants requiring INR monitoring (such as warfarin or similar medications), are not eligible for participation. Treatment with anti-platelet agents and low molecular weight heparin is also excluded. 3. Patients with clinically significant ascites that cannot be controlled with medication, as determined by physical examination, are excluded from the study. 4. Individuals who have been clinically diagnosed with hepatic encephalopathy within the past 6 months and have not responded to treatment are not eligible for participation. Subjects with hepatic encephalopathy controlled with rifaximin or lactulose during the screening period are also excluded. 5. Participants with a medical contraindication to receive contrast-enhanced imaging (such as CT or MRI) are not included in the study. 6. Patients with gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that may interfere with the absorption of the targeted drug are excluded. 7. Individuals with existing grade =3 gastrointestinal or non-gastrointestinal fistula are not eligible to participate. 8. Patients who have clinically significant haemoptysis or tumour bleeding of any cause within 2 weeks prior to the first dose of the study intervention are excluded. 9. Subjects with poorly controlled cardiac clinical signs or diseases, including cardiac insufficiency (determined by cardiac ultrasound: LVEF 450ms (men) or QTc >470ms (women) (QTc intervals are calculated using the Fridericia formula), are not eligible for participation. 10. Participants who have undergone major surgical treatment within 4 weeks prior to enrollment or expect to require major surgical treatment during the study period are excluded. 11. Individuals who have used strong CYP3A4/CYP2C1 inducers (including rifampicin and its analogues) and onychomycin, or strong CYP3A4/CYP2C19 inhibitors within 2 weeks prior to enrollment, are not included in the study. 12. Presence of a severe unhealed wound, ulcer, or fracture. 13. Receipt of any systemic chemotherapy, including anti-VEGF therapy, or any systemic anti-cancer drug for HCC. 14. Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs acting on another stimulatory or co-suppressive T-cell receptor (e.g., CTLA-4, OX-40, or CD137). 15. Previous local treatment (e.g., TACE, transarterial embolization, TARE, hepatic artery perfusion, ablation, or radiotherapy) of an existing liver lesion. Prior use of ablation and resection is allowed if performed more than 4 weeks prior to the first TAIT treatment. Prior use of other local treatments for regressed lesions is allowed if performed more than 6 months prior to the first TAIT treatment. 16. Administration of a live vaccine within 30 days before the first dose of the study drug. Live vaccines include, but are not limited to, measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Injectable seasonal i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Quality of life score; | — |
Countries
China
Contacts
Public ContactWuhua Guo
Mengchao Hepatobiliary Hospital of Fujian Medical University
Outcome results
None listed