Primary hepatocellualr carcinoma
Conditions
Interventions
experimental group:continous portal vein infusion chemotherapy
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The age is between 18-70 years old. 2) PS score <= 2. 3) Patients with primary liver cancer diagnosed by histology or cytology; or meet the diagnostic criteria in the domestic 2019 liver cancer guidelines. 4) Patients with stage BCLC stage C or Chinese stage IIIA HCC who are confirmed by radiographic images of portal vein tumor thrombus formation in main trunk and at least one of the left or right branch of the portal vein is still unobstructed. 5) The patient is naive treatment or undergoes recurrent lesions after radical therapeutic treatment such as surgical resection or radical ablation. 6) According to the Chinese Expert Consensus on the Multidisciplinary Diagnosis and Treatment of Hepatocellular Carcinoma with Portal Vein tumor Thrombosis (2018 Edition), intrahepatic tumors are unresectable. 7) Appropriate organ function: Liver function Child-paugh score <= 8, coagulation function PT prolongs no more than 5 seconds , APTT prolongs no more than 10 seconds. White blood cell count is higher than 3*109/L, absolute neutrophil count is higher than 1.5*10^9/L, and platelet count is higher than 75*10^9/L. The serum creatinine value was lower than 1.5 times the upper limit of normal. 8) Those whose survival time is expected to be more than 3 months. 9) Those who can not accept sorafenib, lenvatinib and other international standard first-line treatment for objective reasons.
Exclusion criteria
Exclusion criteria: 1) Those with complete occlusion of both the left and right portal vein branch of main trunk; those with tumor thrombus that extensively involves the superior mesenteric vein or splenic vein. 2) Patients during pregnancy. 3) Those who are allergic to iodine or oxaliplatin, raltitrexed. 4) Those with extra-hepatic metastasis. 5) Concomitant other diseases may affect treatment tolerance, such as failure to control high blood pressure, diabetes, recurrent myocardial ischemia, severe pulmonary heart disease, and cardiopulmonary dysfunction. 6) Other contraindications to hepatic artery chemotherapy infusion. 7) Total bilirubin is greater than 3 times the upper limit of normal, and alanine or aspartate aminotransferase is 5 times higher than the upper limit of normal. 8) Those who have received multiple lines palliative local treatments such as TACE, iodine-125 seed implantation, tumor thrombus radiotherapy, and ablation treatment; patients who have received systemic treatment such as molecular targeted therapy, immunotherapy, or systemic chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| patency time of portal vein stent; progression-free survival;overall survival;life quality evaluation; | — |
Countries
China
Contacts
Public ContactYu Wenchang
Fujian Cancer Hospital
Outcome results
None listed