HCC with PVTT
Conditions
Interventions
experimental group:neoadjuvant radiotherapy combined with anti-PD-1 and operation
control group:neoadjuvant radiotherapy combined with operation
Sponsors
Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Patients voluntarily participate in this study and sign informed consent; 2) Between the ages of 18 and 70, regardless of gender; 3) The primary liver tumor can be resected; 4) Liver function Child A 5) ECOG score: 0-1 6) Expected survival >= 12 weeks 7) The functions of vital organs are combined with the following requirements: Hemoglobin >= 90g/L Neutrophils count >= 1.5 x 10^9/L Platelet count >= 60 x 10^9/L Serum albumin number >= 30g/ L Total bilirubin 1000 copies/ml, oral antiviral drugs should be taken at least 1 week in advance before chemotherapy. 9) Use of a medically approved contraceptive method (such as iUDS, contraceptives or condoms) during the study period and within 3 months after completion of treatment for women of non-surgical sterilization or childbearing age;Non-surgically sterilized women of childbearing age must be negative for serum or urine HCG within 72 hours prior to study enrollment; and it must be non-lactation.
Exclusion criteria
Exclusion criteria: 1) Allergic to PD-1 monoclonal antibody; 2) Patients who had received radiation therapy, TACE and hormone therapy before and after the completion of treatment (the last medication) were studied less than 4 weeks before the medication; 3) there are not well controlled cardiac clinical symptoms or diseases, such as: (1) heart failure of grade 2 or above, unstable angina pectoris; (2) Myocardial infarction occurred within 1 year; (3) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; 4) Random before 3 months there have been significant clinical significance of bleeding symptoms or have a definite bleeding tendency, such as gastrointestinal bleeding, there is a risk of bleeding of esophageal gastric varices, hemorrhagic peptic ulcers, or patients with vasculitis, baseline period if defecate occult blood positive need to review, if still not turn to gastroscope and enteroscope examination, if the gastroscope prompt severe esophageal gastric varices with red sign is not into the group; 5) Genetic or acquired bleeding and thrombotic tendencies known to exist (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.); 6) urine routine suggested urinary protein >= ++ and confirmed 24-hour urinary protein amount >1.0g; 7) The patient had active infection, fever >= 38.5 degrees C for unknown reasons within 7 days before medication, or white blood cell count >= 15*10^9/ L at baseline; 8) INFECTION with HCV, HIV or syphilis; 9) Patients with other malignant tumors within 3 years or at the same time; 10) Patients suffering from chronic headaches or migraines, which cannot be relieved by taking medication; 11) The researchers believe that the participants should not be enrolled for other reasons, such as severe mental illness, substance abuse, family or social factors, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;AFP;tumor marker; | — |
Countries
China
Contacts
Public ContactCheng Shuqun
Eastern Hepatobiliary Surgery Hospital
Outcome results
None listed