Unresectable liver cancer
Conditions
Interventions
Group A:As2O3 drug-loading embolization microspheres in TACE
Group B:doxorubicin or pirarubicin drug-eluting beads in TACE
Group C:iodine oil-As2O3 in TACE
Sponsors
Department of Interventional medicine, the First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. single or 2-3 tumors with diameters greater than or equal to 5cm, tumor stage: BCLC stage was b-c stage, non-diffuse liver cancer; 2. Patients with recurrent/metastatic HCC who meet the clinical diagnostic criteria or have been confirmed by histopathological or cytological examination, and they cannot accept palliative surgery or radiation therapy.And there is a lesion can be measured at least(according to mRECIST version 1.1 requirements, the measurable lesion spiral CT scan long diameter = 10mm or enlarged lymph node short diameter = 15mm); there is no liver transplantation, surgical excision, TACE, radiofrequency/microwave/chemical ablation, argon-helium knife, ultrasound knife, radiotherapy and other treatments were performed after confirmation of liver cancer; 3. The gender of the patient is not limited, aged from 18 to 75 years; 4. ECOG PS score (within 1 week before enrollment) 0-1; 5. Liver tumor occupation rate is less than 60% of total liver volumeand life expectancy is 3 months; 6. The patient has no serious comorbidities such as hypertension, coronary heart disease and psychiatric history, no serious history of allergies; 7. Liver function should reach Child-Pugh grade A or B, Renal function is normal; Coagulation is normal or corrected after treatment; 8. HBV DNA<2000 IU/ml (104 copies/ml); 9. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment; 10. The patient signed an informed consent form that agreed to participate in the trial study; it was able to follow up and was well compliant.
Exclusion criteria
Exclusion criteria: 1. Imaging examination revealed massive liver tumors (60% or greater liver volume)Cancer bolt exists in the main portal vein (occupying 50% or more of the vascular diameter)The cancer plug invaded the mesenteric or inferior vena cavaBefore participating in this study, the patients received liver transplantation, surgical excision, TACE, radiofrequency/microwave/chemical ablation, argon-helium knife, ultrasound knife, radiotherapy and other treatments; 2. Diffuse liver cancer patientThe patient is known to be diagnosed with hepatobiliary and mixed cell carcinoma and fibrosarcomaThe patient has a history of (5 years) or other incurable malignancies at the same timeexcept for cured basal cell carcinoma of the skin and cervical carcinoma in situ; 3. With above level II myocardial ischemia or myocardial infarction, poor control of arrhythmia (including mens QTc interval=450 ms ,womens QTc interval=470 ms); 4. In the past 6 months, the patient had a history of gastrointestinal bleeding or had a clear tendency of gastrointestinal bleeding, such as esophageal varices which are at risk of bleeding, local active ulcer lesions and fecal occult blood (++); If fecal occult blood (+), a gastroscopy is required; 5. The patient has abnormal coagulation function(INR>1.5 or PT> ULN+4 second)has bleeding tendency or is receiving thrombolytic or anticoagulant treatment; 6. Patients with central nervous system metastasis or known brain metastasesPatients with previous and present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impairment of pulmonary functionCombined HIV-infected patients; Pregnant or lactating patient; Patients is preparing for liver transplantation (except for patients with previous liver transplantation); 7. Systemic organ failure, expected survival <3 months; 8. The treatment plan could not be completed for various reasons, and the patient lost within 3 months after enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression free survival;To the time of disease progression;Duration of Response;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactXuhua Duan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed