Hepatocellular carcinoma
Conditions
Interventions
Treatment 1:SBRT(radiotherpay dose was 25-50Gy/5F) plus HAIC
Sponsors
Peking University Cancer Hospital Inner Mongolia Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18-75 years old, male or female. 2) Patients with hepatocellular carcinoma (programmed type II-III) confirmed by imaging or pathology cannot be surgically resected after surgical evaluation. 3) Portal vein cancer thrombus was confirmed by imaging and did not achieve complete remission after systemic therapy, or systemic therapy was not tolerated by doctors, or the patient refused systemic therapy. 4) Child-Pugh score: Grade A or good grade B (=8 points). ALT, AST < 2.5 times upper limit of normal, ALP < 2.5 times upper limit of normal, total bilirubin < 1.5 times upper limit of normal, PT < 1.5 times upper limit of normal, INR < 1.5, ALB =29g/L. 5) ECOG score in the first week of enrollment: 0-1. 6) Hematological tests were consistent with: HGB =90g/L, ANC =1.5× 10^9 /L, PLT =75× 10^9 /L, WBC =3.0× 10^9 /L; Creatinine =1.5ULN. 7) Patients with active hepatitis B virus (HBV) infection: HBV-DNA < 500 IU/mL (< 2500 copy/mL if the study center only has copy/mL testing units) and receiving anti-HBV therapy for at least 14 days prior to the start of study therapy; Hepatitis C virus (HCV) RNA positive patients must receive antiviral therapy according to standard local treatment guidelines and have liver function within CTCAE grade 1 elevation. 8) Women of reproductive age (generally 15-49 years) must undergo a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and within 8 weeks after the last dose of the study drug; For men, they should be surgically sterilized or consent to an appropriate method of contraception during the observation period and for 8 weeks after the last administration of the study drug. 9) No previous liver radiotherapy. 10) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1) Age > 75. 2) ECOG score =2 points. 3) Poor liver function, Child-Pugh > 7 or liver enzyme, coagulation, bilirubin, bone marrow function did not meet the eligibility criteria. 4) Esophageal and gastric varices rupture bleeding (active), hepatic encephalopathy, massive ascites, abdominal infection history. 5) Lung, bone, mediastinal lymph nodes, abdominal lymph nodes, pelvic lymph nodes and other extrahepatic metastases. 6) The tumor is close to the intestines and other dangerous organs, and it is difficult to tolerate radiotherapy; Residual liver volume 450 ms in men and >470 ms in women, QTcF interval calculated by the Fridericia formula), symptomatic congestive heart failure; Such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism. 11) Abnormal coagulation function (INR>1.5 or APTT>1.5×ULN), bleeding tendency or receiving thrombolytic therapy, anticoagulant therapy or antiplatelet therapy; 12) Known history of psychotropic substance abuse or drug use. 13) The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, as well as patients deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival;Overall Survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactXianggao Zhu
Peking University Cancer Hospital Inner Mongolia Hospital
Outcome results
None listed