liver cancer
Conditions
Interventions
experimental group:Microwave ablation combined with anti-PD-1 antibody and bevacizumab
Sponsors
Affiliated Hospital of Yunnan University (The Second People's Hospital of Yunnan Province)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Advanced recurrent liver cancer proved histopathologically, with tumor stage B-C of BCLC. These include hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC). (2) Radiological evidence of tumor recurrence or progression with previous surgical resection (based on Mrecist 1.1, presence of radiologically measurable intrahepatic lesions, single 3 months. (5) ECOG PS score was 0 or 1 within 1 week of inclusion. (6) No serious complications, such as hypertension, coronary heart disease and psychiatric history, no history of serious allergy; Women of childbearing age should have a pregnancy test within 7 days before enrollment. (7) The functions of the patient's organs and blood system meet the requirements: Blood system function: absolute neutrophil count (ANC) >= 1.5 x 109/L, platelet count >= 100 x 109/L, lymphocyte percentage >= 10%; Renal function: Estimated glomerular filtration rate or creatinine clearance > 50 mL/min/1.73 m2; Liver function: Total bilirubin <= 2 x ULN, AST and ALT <= 2 x ULN, Child-Pugh grade A or B. (8) HBV DNA < 2000 IU/ mL (104 copies/mL). (9) Patients can understand and sign the informed consent to participate in the study; Can follow up, compliance is good.
Exclusion criteria
Exclusion criteria: (1) Imaging examination of liver cancer tumor >5.0cm, or the number of BBB>, or portal main tumor thrombus (occupying vascular diameter >= 50%), or tumor thrombus invading mesenteric vein or inferior vena cava. Before participating in this study, he had received liver transplantation, TACE, radiofrequency/microwave/chemical ablation, argon-helium knife, ultrasound knife, radiotherapy and other treatments. (2) Previous (within 5 years) or co-existing uncured malignancies, including cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; (3) Patients had undergone major surgery within 2 weeks prior to enrollment. (4) 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, severe pulmonary impairment, etc.; Combined with HIV infected patients; Pregnant or lactating patients; Patients who are preparing for liver transplantation (except those who have received previous liver transplantation). (5) With myocardial ischemia and myocardial infarction II class above, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher) (6) A history of gastrointestinal bleeding or a definite tendency of gastrointestinal bleeding within the previous 6 months, such as esophageal varicose veins with bleeding risk, local active ulcer lesions, or fecal occult blood >= (++) were not included in the group; If occult blood in stool (+), gastroscopy is required. (7) Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) BBB>N + 4 SEC), bleeding tendency or receiving thrombolytic or anticoagulant therapy; (8) The patient has, or has a history of, any clinically significant disease that the Investigator considers to be likely to jeopardize patient safety or the reliability of the study results. (9) Systemic failure, the expected survival time is less than 3 months; (10) Unable to complete the treatment plan for various reasons and lost follow-up within three months after enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;DOR;1, 2 year survival rate;security; | — |
Countries
China
Contacts
Public ContactZhao Jian
Affiliated Hospital of Yunnan University (The Second People's Hospital of Yunnan Province)
Outcome results
None listed