Unresectable advanced hepatocellular carcinoma
Conditions
Interventions
Experimental group:This combined regimen consists of hepatic artery injection of Bevacizumab (300 mg on day 1, over 2 hours), followed by Oxaliplatin (85 mg/m2 on day 1, arterial infusion for 2-3 hour
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in this study and sign the informed consent form; 2.=18 years old (calculated from the date of signing the informed consent); 3.Hepatocellular carcinoma with a clear clinical or pathological diagnosis; 4.BCLC stage B or C, with vascular/biliary invasion or distant metastasis excluded (with Vp type 4 tumor thrombus excluded); 5.Has not received systemic treatment for liver cancer; Or for those who have experienced progression or residual lesions after local treatment for liver cancer (including but not limited to surgery, ablation, radiotherapy, TACE, etc.), the time between local treatment and enrollment should be no less than one month. 6.ECOG PS score: 0-1 point; 7.Child Pugh score A or B (< 7 points); 8.No history of autoimmune diseases; 9.Life expectancy =3 months; 10.At least one measurable lesion (according to RECIST v1.1 requirements, the long diameter of the measurable lesion on spiral CT scan is =10 mm or the short diameter of the enlarged lymph node is =15 mm; lesions that have received local treatment in the past can be used as target lesions after clear progression according to RECIST v1.1 standards); 11.Adequate blood, liver and kidney functions. 12.Women of childbearing age should have a negative serum or urine pregnancy test within 7 days before enrollment in the study, must be non-lactating patients, and agree to use contraceptive measures during the study period and for 6 months after the study ends. Men should agree that they must use contraception during the study period and for six months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1.Patients with contraindications to HAIC; 2.Within one month before enrollment, immunosuppressants or systemic hormone therapy were used to achieve the purpose of immunosuppression; 3.Those with active infections that cannot be effectively controlled; 4.Severe gastric fundus esophageal varices; Untreated or incompletely treated gastric fundus esophageal varices (with bleeding or a high risk of bleeding); 5.Bone metastases accompanied by brain metastases or requiring emergency intervention from surgery or radiotherapy departments; 6.Pregnant or suspected of being pregnant, or breastfeeding; 7.Aspirin (325mg/ day (maximum antiplatelet dose) or dipyridamole, clopidine, clopidogrel and cilostazole are currently being used or have been used recently (within 10 days before the start of the study treatment); 8.Thrombosis or embolism events occurred within 6 months prior to the start of the study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc. 9.The patient has congenital or acquired immune deficiency; 10.Accompanied by a history of other malignant tumors; 11.Any of the following conditions occurred 12 months before the start of the study: myocardial infarction, severe/unstable angina pectoris, congestive heart failure; 12.Patients with renal insufficiency who need dialysis; 13.Have a history of organ transplantation in the past; 14.Patients with other serious acute or chronic physical or mental disorders or abnormal laboratory tests that may increase research risks or interfere with result interpretation and are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactSun Shijie
Yantai Yuhuangding Hospital
Outcome results
None listed