Liver cancer
Conditions
Interventions
experiment group:anti-angiogenic targeted drugs combined with PD-1 inhibitors and radiotherapy
Retrospective group:NA
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 2. no gender limitation 3. HCC patients who strictly met the clinical diagnostic criteria of The Code for The Diagnosis and Treatment of Primary Liver Cancer (2019 edition) or were confirmed by histopathological or cytological examination 4. BCLC stage C, no distant metastasis; 5. Patients with PVTT of type I-IIIa according to Cheng’s Classification; 6. The primary tumor can be resected (the remaining liver has complete vascular structure and sufficient liver volume, in line with the decision-making system of safe liver resection) 7. ECOG score 0-1; 8. Child-Pugh score = or equal to 1.5 X 10 ^ 9 per liter (/ L)) Hemoglobin (Hb >= 8.5 g/dL) Platelet count >= 75×10 ^ 9 / L. 2) Adequate liver function, defined as: Albumin > 2.8 g/dL Bilirubin is 3.0 mg/dL or less Aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanine aminotransferase (ALT) are less than or equal to 5 ULN. 3) Adequate coagulation function, defined as an international standardized ratio ( (INR) of 2.3 or less. 4) Adequate renal function was defined as creatinine clearance greater than 40 mL/min (mL/min), calculated according to the Cockcroft and Gault formulas. 5) Adequate pancreatic function, defined as amylase and lipase. = 1.5 x ULN. 11. Adequate control of blood pressure (BP) with up to 3 antihypertensive drugs, defined as BP-lt at screening time; <= 150/90 mmHg (mmHg), and there was no change in antihypertensive therapy 1 week prior to cycle 1 / day 1. 12. Patients are expected to survive longer than 3 months. 13. No pregnancy or pregnancy plan. 14. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Extrahepatic metastasis of primary hepatocellular carcinoma 2. Diffuse liver cancer 3. Patients who had previously received targeted drugs or immune checkpoint inhibitors 4. allergic to Lenvatinib or PD-1 inhibitor ingredients 5. Patients with grade II or higher myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (including QTc interval =470 ms) 6. abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT > 1.5ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy 7. pregnant or breast-feeding women;Fertile patients unwilling or unable to take effective contraceptive measures 8. have a history of mental illness or abuse of psychotropic drugs 9. patients with co-HIV infection 10. a history of liver resection, liver transplantation, interventional therapy, and other malignant tumors 11. patients with active infection 12. contraindications to radiotherapy 13. Patients with poor compliance such as floating population 14. participants in clinical trials of other experimental drugs or devices within 4 weeks 15. those considered unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and feasibility;1-year disease-free survival rate (DFS rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response;Objective Response Rate;PVTT Regression rate;Consistency rate between preoperative imaging and postoperative pathological assessment;Overall survival;Recurrence-free survival;1-year recurrence-free survival rate (RFS rate); | — |
Countries
China
Contacts
Public ContactGuangxin Li
Beijing Tsinghua Changgung Hospital
Outcome results
None listed