Hepatocellular carcinoma
Conditions
Interventions
A Group:DEB-TACE combined with apatinib
B Group:DEB-TACE
Sponsors
Department of Interventional Medicine, the First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Unresectable HCC patients with recurrence / metastasis confirmed by histopathology or cytology, who strictly comply with the clinical diagnostic criteria of the "diagnostic and therapeutic criteria for primary liver cancer" (2017 Edition), are unable to receive palliative surgery or radiotherapy, and have at least one measurable lesion (according to mrecist) Version 1.1 requires that the long diameter of the measurable lesion should be greater than or equal to 10 mm or the short diameter of the enlarged lymph node should be greater than or equal to 15 mm; after confirming the liver cancer, no immunotherapy including liver transplantation, surgical resection, TACE, radiofrequency / microwave / chemical ablation, argon helium knife, ultrasonic scalpel, radiotherapy, systemic chemotherapy, oral liver cancer targeting drugs (sorafenib, renfatinib, apatinib) and PD-1 / PD-L1 / cdla-4 were not performed. (2) Tumor stage: BCLC stage was B-C stage, non diffuse liver cancer; (3) The age of the patients ranged from 18 to 75 years old; (4) ECoG PS score within 1 week before enrollment: 0-1; (5) Liver tumor accounted for less than 60% of life expectancy; (6) No serious complications, such as hypertension, coronary heart disease and mental history, no severe allergic history; (7) Liver function should reach child Pugh grade A or B, renal function and coagulation function should be normal or corrected after treatment; (8) HBV DNA < 2000 IU / ml (104 copies / ml); (9) Women of childbearing age should have pregnancy test within 7 days before enrollment; (10) The patients signed the informed consent to participate in the trial, and had good compliance.
Exclusion criteria
Exclusion criteria: (1) Imaging examination showed that HCC liver tumor was huge (>= 60% liver volume), or tumor thrombus in main portal vein (occupying vessel diameter >= 50%), invasion of mesenteric vein or inferior vena cava, or obvious arteriovenous fistula; (2) Before participating in the study, he had received liver transplantation, surgical resection, TACE, radiofrequency / microwave / chemical ablation, argon helium knife, ultrasonic scalpel, radiotherapy and other local treatments. He had also experienced systemic chemotherapy, oral targeted liver cancer drugs (sorafenib, renfatinib, apatinib) and immunotherapy such as PD-1 / PD-L1 / cdla-4; (3) Patients with diffuse liver cancer; known cholangiocarcinoma, mixed cell carcinoma and fibrolamellar cell carcinoma; previously (within 5 years) or at the same time suffering from other uncured malignant tumors, except for skin basal cell carcinoma and cervical carcinoma in situ that have been cured; (4) Patients with grade II or above myocardial ischemia or myocardial infarction and arrhythmia with poor control (including QTc interval >= 450 ms in male and >= 470 MS in female); (5) In the past 6 months, patients with history of gastrointestinal bleeding or with clear gastrointestinal bleeding tendency, such as esophageal varices with bleeding risk, local active ulcer lesions, fecal occult blood >= + +, can not be included in the group; if fecal occult blood (+), gastroscopy is required; (6) Patients with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds) had bleeding tendency or were receiving thrombolytic or anticoagulant therapy; (7) Patients with central nervous system metastasis or known brain metastasis; patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, radiation pneumonitis, drug-related pneumonia, severe lung function impairment, etc.; patients with joint HIV infection; pregnant women or breast-feeding patients; patients preparing for liver transplantation (except for patients with previous liver transplantation). (8) The overall survival time was less than 3 months; (9) Creatinine clearance rate (CR) was less than 2 mg / min (CR < 2 mg / min); (10) Due to various reasons, the treatment plan could not be completed, and the patients were not followed up within three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;OS;TTP;ORR;DCR; | — |
Countries
China
Contacts
Public ContactXuhua Duan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed