Primary liver cancer
Conditions
Interventions
Single arm experimental group:hepatic artery infusion chemotherapy + molecular targeted therapy + Immunotherapy +Radiation therapy
Sponsors
The Third Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in the study and signed informed consent; 2. Aged 18 years old and above, male or non-pregnant or lactating female; 3. Newly treated patients with primary liver cancer confirmed by clinical diagnosis or pathology; 4. Subjects with stage IIB to Stage IIIB liver cancer according to the Barcelona clinical stage B or C primary liver cancer or according to the 2019 Edition of primary Liver Cancer Diagnosis and Treatment Guidelines issued by the National Health Commission (see Appendix 1 for staging criteria) and whose disease is not suitable for radical surgery; Or the presence of extrahepatic metastasis (diagnosed as extrahepatic metastasis by three hepatocellular carcinoma diagnosis and treatment experts with associate senior titles or above in our hospital); 5. ECOG score of body state = 12 weeks; 9. No esophageal or gastric variceal bleeding event caused by portal hypertension occurred in the last 6 months; 10. Three liver cancer diagnosis and treatment experts in our hospital (deputy senior title or above) evaluated as inoperable.
Exclusion criteria
Exclusion criteria: 1. Previous history of radiotherapy at the same site; 2. Abnormal heart, lung, liver and kidney function; 3. Multiple factors affecting oral drugs (such as inability to swallow, ulcers, chronic diarrhea, intestinal perforation, intestinal obstruction, etc.); 4. Severe lung infection, or active infection of the whole body, pericardium or other parts, fever of unknown cause >= 38.5? within 7 days before treatment, or white blood cell count /PD-L1 at baseline > 15×10^9/L; 5. The patient has a history of other malignant tumors except liver cancer; 6. Patients were taking immunosuppressant or systemic hormone therapy for immunosuppression purposes (dose > 10mg/ day of prednisone or other equivalent hormone) and continued to use within 2 weeks prior to enrollment; 7. Known history of hepatic encephalopathy or history of organ transplantation; 8. Diffuse liver cancer: Diffuse liver cancer is defined as tumor nodules scattered throughout the liver, with intrahepatic invasion of > 50% or > 10 lesions, or locally advanced manifestations (at least one lesion > 10 cm, vascular invasion, or multiple lesions with at least one lesion > 6 cm); 9. Any other conditions that the investigator considers unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Duration of Response;6-month survival rate;6-month survival rate;12-month progression free survival rate;12-month survival rate; | — |
Countries
China
Contacts
Public ContactLin Nan
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed