Hepatocellular carcinoma
Conditions
Interventions
Group B:Radiation embolization therapy
Group A:Radioembolization combined with continuous hepatic artery infusion chemotherapy
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join the group and sign a written informed consent form; 2. Age range of 18-80 years old, male or female not limited; 3. Diagnosis of liver cancer in patients based on AASLD HCC management guidelines and clinical or pathological HCC diagnosis based on American Association for the Study of the Liver standards; 4. The included patients should be Barcelona stage A or B HCC patients with at least one lesion >= 7cm, and not suitable for surgical or liver transplant treatment; 5. Has not received systemic treatment. Patients who have undergone local treatment followed by adjuvant chemotherapy can also be included if more than 12 months have passed since the end of chemotherapy, and they have experienced disease progression or metastasis. 6. The end time of the last TACE, radiotherapy, and ablation treatment is more than 4 weeks. 7. Patients who have previously undergone hepatectomy should have achieved R0 resection, and tumor recurrence should occur more than 24 months postoperatively; 8. At least one assessable lesion (RECIST 1.1 criteria); 9. Expected survival time >= 3 months Can cooperate to observe adverse events and therapeutic effects; 10. The physical condition (PS) score of the Eastern Cancer Collaboration Group (ECOG) rana) Hemoglobin >= 90 g/L; 11. Child Pugh score = 75 × 10^9/L; 12. Able to collaborate in observing adverse events and efficacy. 13. Primary organ functions are normal, meeting the following criteria: Complete blood count test (no blood transfusion or use of G-CSF within 14 days before screening): a) Hemoglobin >= 90 g/L; b) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; c) Platelet count >= 75 × 10^9/L; Biochemical tests (no albumin use within 14 days before screening): d) Albumin >= 28 g/L; e) Total bilirubin <= 2 × upper limit of normal (ULN); f) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 5 × ULN; g) Alkaline phosphatase (ALP) <= 5 × ULN; h) Creatinine <= 1.5 × ULN; Coagulation function: i) International normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN; Activated partial thromboplastin time (APTT) <= 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1. Child-Pugh C grade liver dysfunction, severe hepatic impairment (hepatic encephalopathy, refractory ascites, hepatorenal syndrome, etc.); 2. The pulmonary shunt fraction of 99mTc-MAA exceeds 20%, with an estimated single lung absorption dose greater than 30 Gy or an accumulated absorption dose greater than 50 Gy; 3. Irreversible hepatic arteriovenous fistula or hepatic artery-gastrointestinal artery fistula; 4. The liver tumor has previously received radiotherapy or systemic treatment; 5. acute infection or sepsis; 6. during pregnancy; 7. Patients with impaired heart function or poor lung function; 8. Expected survival period is less than three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Objective response rate;surgical conversion rate;Quality of life; | — |
Countries
China
Contacts
Public ContactZhuting Fang
Fujian Cancer Hospital
Outcome results
None listed