hepatocellular carcinoma
Conditions
Interventions
Experimental group:radiotherapy in combination with lenvatinib
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed or in line with the clinical diagnostic criteria for hepatocellular carcinoma. 2.Have a history of hepatitis B infection for more than half a year, HBsAG (+), HBcAB (+) Included patients were hepatocellular carcinoma with cancer thromboembolus that could not be surgically removed or progressed after surgical and other local/regional treatment (radiofrequency, intervention, etc.). 3.The following criteria were met: type II or type III portal vein cancer thrombus was diagnosed according to cheng's classification criteria. Number of tumors in liver parenchyma: less than or equal to 3, with at least one evaluable lesion. 4.Child-pugh grade A for liver function. 5.The ECOG score is 0-1. 6.Estimated time of survival > 3 months. 7. Age =18 and =75 years old. 8. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with the following conditions: Diffuse liver cancer; Liver parenchyma tumor lesions in more than 3 places; Or the total length of > 15cm of marked liver disease. 2.Patients with signs of extrahepatic metastasis, including but not limited to inferior vena cava cancer thromboembolus, bone metastasis, brain metastasis, or regional lymph node metastasis. 3.A history of West Haven Standard Grade III IV hepatic encephalopathy or ascites Patients with a history of malignancy. 4.Other than primary HCC were excluded from cutaneous squamous cell carcinoma or basal cell carcinoma. 5.Patients with a history of upper abdominal radiation therapy. 6 In the radiotherapy plan, patients who failed to follow the dose limitation of vital organs, including patients with normal liver tissues less than 700ml in the radiotherapy plan. 7.Patients who had been treated with other study drugs in the 4 weeks prior to screening visits 8.Patients who had received other local or systemic therapies for hepatocellular carcinoma in the 4 weeks prior to screening visits. 9.Patients with significant concurrent disease, such as: Active coronary artery disease or a history of myocardial infarction in the past 6 months; New York heart association (NYHA) grade > 2 heart failure; Receive hemodialysis or peritoneal dialysis Active and uncontrolled infections, with the exception of chronic viral hepatitis; Human immunodeficiency virus (HIV) infection; Uncontrolled or uncontrollable diabetes; There was an untreated active gastrointestinal bleeding within 30 days; To receive organ transplantation, including but not limited to liver transplantation; A history of alcohol or drug abuse within 3 months. 10.Women who are pregnant, lactating, or planning to conceive
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| overall survival;disease control rate;objective response rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Countries
China
Contacts
Public ContactJiazhou Hou
Zhongshan Hospital Fudan University Shanghai China
Outcome results
None listed