hepatocellular carcinoma
Conditions
Interventions
Experimental group:methylene blue-fluorouracil
Sponsors
People's Hospital of Jianyang City
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with recurrent HCC who strictly meet the clinical diagnostic criteria or are diagnosed by pathological tissue or cytological examination according to the "Primary Liver Cancer Diagnosis and Treatment Guidelines" (2020 edition), are in BCLC-A/B/C stage, are not suitable for surgery, and have at least one measurable lesion (according to the mRECIST standard, the measurable lesion must have a long diameter of >= 10mm or a short diameter of >= 15mm on spiral CT scan or enlarged lymph node); 2. Liver function Child-Pugh level A or B, which needs to be determined based on clinical presentation and laboratory examination data during the screening period (Appendix 4); 3. ECOG-PS performance status 0 or 1 (Appendix 3); 4. Expected survival >= 12 months; 5. Age 18-75, regardless of gender; 6. Patients with large-bulk type liver cancer with tumor occupying less than 70% of the liver; 7. Patients who refuse standardized cancer treatment for various reasons (especially economic reasons); patients who have progressed more than 4 weeks after surgery, immunotherapy, targeted therapy, or radiotherapy, and have not received other anticancer treatment (after washout period); 8. Laboratory test results meet the following requirements: (1) Total bilirubin 1,500/µL; (4) Platelets > 75,000/µL; (5) Serum uric acid 1.5 times the upper limit of normal, creatinine clearance must be >= 60 mL/min/1.73 m2; (7) Serum albumin level >= 2.8g /dL; (8) Prothrombin time (PT) - International Standardized Ratio (INR) : PT < reference +6 s or INR < 1.7; Subjects treated with coumarin anticoagulants should have an INR of 1; 9. Subjects with active hepatitis B or C can be treated with antiviral drugs other than interferon; 10. Before the trial began, the patients volunteered and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe infection at enrollment or within 7 days prior to initial administration requiring systemic antibiotic treatment; 2. Pregnancy or lactation; 3. Patients with mental illness, especially those who are taking antipsychotic drugs such as serotonin, have poor compliance; 4. Uncontrollable interrecurrent diseases (including but not limited to) infections, symptomatic congestive heart failure (New York Heart Association standard, Class III or IV), arrhythmias, mental disorders; 5. Subjects who have received other anti-cancer therapy and have not returned to baseline (except hair loss) or >= grade 1 AE; 6. Subjects had a history of other primary cancers, including coexisting secondary malignancies; 7. Be HIV positive; 8. Patients preparing for liver transplantation (other than those who have previously undergone liver transplantation); 9. Portal hypertension caused by liver cancer rupture and bleeding and hepatic arterio-portal shunt; 10. Received palliative radiotherapy within 4 weeks (radiotherapy area > 5% bone marrow area); 11. Other conditions in which the patient was considered inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidene of adverse reactions/events;Objective Response Rate;Local progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| MRI performance; | — |
Countries
China
Contacts
Public ContactFeng Shou
People's Hospital of Jianyang City
Outcome results
None listed