C-TACE resistant unresectable hepatocellular carcinoma
Conditions
Interventions
Case series:CalliSpheres drug-loaded embolic microspheres loaded with epirubicin for arterial embolization
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 ) Age: = 18 - 75 years old, expected survival = 12 weeks; 2 ) Non - resectable HCC patients who strictly meet the clinical diagnostic criteria or are diagnosed with recurrence / metastasis by histopathological or cytological examination, cannot receive palliative surgery or radiotherapy, and have at least one measurable lesion ( the spiral CT scan length diameter of the measurable lesion is = 10 mm according to RECIST Version 1.1 ); The target lesion has not received local treatment. 3) Child-Pugh liver function rating: grade A or better grade B ( = 7 ); 4) BCLC stage is B-C stage; 5 ) ECOG PS score within 1 week before admission: 2 points; 6 ) He has received 2 - 3 times of c-TACE treatment before and suffered from c-TACE resistance: the volume of tumor necrosis or inactive lesions is less than 50% assessed by imaging examination on the premise that new lesions appear in liver or tumor feeding arteries are completely embolized through imaging examination and tumor index detection. 7 ) The main organs function normally; 8 ) Subjects voluntarily joined the study, signed informed consent form, had good compliance and cooperated with follow - up.
Exclusion criteria
Exclusion criteria: 1 ) Received any local treatment other than TACE ( including surgery, radiotherapy, radiofrequency ablation, cryoablation or percutaneous ethanol injection ) within 2 months prior to admission into the group; 2 ) Those who have participated in chemotherapy or targeted drug therapy within 2 months before joining the group; 3 ) Known hepatobiliary cell carcinoma, mixed cell carcinoma and fiberboard layer cell carcinoma; In the past ( within 5 years ) or at the same time suffering from other incurable malignant tumors; 4 ) Liver function is graded as Child-Pugh C and cannot be improved after liver protection treatment; 5 ) Irreversible coagulation dysfunction and obvious hemogram abnormality with obvious bleeding tendency; 6 ) refractory massive ascites; 7)ECOG physical fitness score is greater than 2 points; 8 ) complicated with active infection, especially inflammation of bile duct system, etc. 9 ) Severe heart, lung, kidney, brain and other important organ diseases; 10 ) Patients and / or their families do not agree to join the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of disease progression;Progress free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective remission rate; | — |
Countries
China
Contacts
Public ContactWei Zhang
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed