hepatocellular carcinoma
Conditions
Interventions
The intervention group:Transarterial chemoembolization (TACE):The interval between the TACE and radiation therapy is 4-6 weeks, and the TKIs should be suspended during the perioperative period (7 days
The intervention group:Stereotactic body radiation therapy (SBRT): patients will receive SBRT within 7 days after the initiation of systemic therapies.
The intervention group:tyrosine kinase inhibitors (TKIs): patients will receive sorafenib (0.4g po bid) , or donafenib (0.2g po bid), or lenvatinib (12mg po qd (body weight = 60kg)
8mg po qd (body weight <60 kg)). Treatment would be terminated if there was disease progression or unacceptable toxicity during treatment.
The intervention group:Patients received 200 mg of sintilimab intravenously over 60 min every 3 weeks. Treatment would be terminated if there was disease progression or unacceptable toxicity during tr
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Patients should sign informed consent before beginning any treatment. Patients must understand and voluntarily sign a written informed consent. 2) Age 18-70 years, and gender is not limited. 3) Hepatocellular carcinoma diagnosed by cytology, histology, or clinical diagnosis by CT, MRI and laboratory examinations, with at least one measurable lesion in the liver on the basis of mRECIST. Portal vein tumor thrombosis (PVTT) was confirmed using the typical radiological patterns and diagnosed as type I-IV according to Cheng's classification criteria (type I, segmental or sectoral branches of the portal vein; II, right- or left-side branch of the portal vein; III, main trunk of the portal vein; and IV, superior mesenteric vein). 4)Interventional therapy and radiation therapy can be performed after multidisciplinary consultation. Patients with =5 extrahepatic metastases, and the maximum diameter of metastases was =3cm. 5) No history of abdominal radiotherapy. 6) Patients who did not receive prior systemic and local therapy before enrollment. 7) Eastern Cooperative Oncology Group (ECOG) score was=1. 8) The expected survival is not less than 3 months. 9) Child-Pugh grade A or B7. 10) No significant abnormalities in organ and bone marrow function (serum creatinine <1.5x ULN, estimated glomerular filtration rate=50 mL/min/1.73m2; Total bilirubin=2x ULN, aspartate aminotransferase=2.5x ULN, alanine aminotransferase=2.5x ULN, aspartate aminotransferase/alanine aminotransferase=3 x ULN; Platelet count= 60×109/L, white blood cell count=3000/mm3, neutrophil absolute value=1500/mm3, blood transfusion is not allowed to meet the criteria)
Exclusion criteria
Exclusion criteria: 1) Evidence of acute or active hepatitis (hepatitis B or hepatitis C) infection, such as HBV-DNA > 2000IU/ml, HCV-RNA > 10^3 copy number per ml. 2) Patients who were diagnosed with autoimmune disease or received liver transplantation 3) Patients who received any treatments before enrollment. 4) Patients with intractable ascites or hepatic encephalopathy. 5) Concurrent malignant tumors of other organs. 6) Patients with impaired organ and system function who cannot tolerate treatment. 7) Pregnant or lactating subjects. 8) Patients that the researchers consider inappropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Objective response rate, ORR;Treatment-related adverse events,TRAEs;Disease Control Rate, DCR; | — |
Countries
China
Contacts
Public ContactXin Wang
West China Hospital, Sichuan University
Outcome results
None listed