Hepatocellular carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) The diameter of single tumor or the sum of 2-3 tumors was more than or equal to 10 cm. The tumor stage was BCLC stage B-C, non diffuse liver cancer; (2) Unresectable HCC patients with recurrence / metastasis who strictly meet the clinical diagnostic criteria of the code for the diagnosis and treatment of primary liver cancer (2017 Edition) or confirmed by histopathology or cytology, and who 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 lesions should be greater than or equal to 10 mm or the short diameter of the enlarged lymph nodes should be greater than or equal to 15 mm; (3) Aged 18 to 75 years; (4) ECoG PS score: 0-1 in the first week; (5) Liver tumor occupied less than 60% of the total liver volume, and the life expectancy was 3 months; (6) No serious complications, such as hypertension, coronary heart disease and psychiatric history, no serious allergic history; (7) Liver function should reach child Pugh grade A or B, renal function should be normal, coagulation function should be normal or be 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 entering the group; (10) The patients signed the informed consent to participate in the study, and were able to follow up with 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 more than 50% of vascular diameter), or tumor thrombus invading mesenteric vein or inferior vena cava. Before participating in the study, liver transplantation, surgical resection, TACE, radiofrequency / microwave / chemical ablation, argon helium knife, ultrasonic knife, radiotherapy and other treatments were performed; (2) Patients with diffuse hepatocellular carcinoma, known hepatobiliary carcinoma, mixed cell carcinoma and fibrolamellar cell carcinoma, previously (within 5 years) or at the same time with other incurable malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ; (3) Patients with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (including QTc interval >= 450 ms in male and >= 470 MS in female); (4) In the past 6 months, patients with a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding, such as esophageal varices with risk of bleeding, local active ulcer lesions, fecal occult blood >=+, can not be included in the group; if fecal occult blood (+), gastroscopy is required; (5) Abnormal coagulation function (INR > 1.5 or PT > ULN + 4 seconds), bleeding tendency or receiving thrombolysis or anticoagulation therapy; (6) Patients with central nervous system metastasis or known brain metastasis; patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung function impairment; patients with combined HIV infection; pregnant women or breast-feeding patients; patients preparing for liver transplantation (excluding patients with previous liver transplantation); (7) Systemic failure, the expected survival time was less than 3 months; (8) The patients were unable to complete the treatment plan for various reasons and were lost to follow-up within three months after enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
The First Affiliated Hospital of Zhengzhou University