Hepatobiliary carcinoma
Conditions
Interventions
Group of radiotherapy combined with polymyocytoid injection treatment:Polymyocytoid injection is injected subcutaneously in the axilla
Sponsors
Mengchao Hepatobiliary Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily joined the study and signed the informed consent; 2. 18-75 years old, male or female; 3. Patients with unresectable recurrent or metastatic liver cancer confirmed by imaging or histological cytology; 4. The treatment plan is radiotherapy alone or radiotherapy combined with targeted drug therapy; 5. According to RECIST v1.1, the response evaluation standard for solid tumors, there is at least one radiotherapy lesion in the liver that can be measured by imaging; 6. CNLC stage IIa-IIb patients who are not suitable/unwilling to undergo surgery, ablation or interventional therapy, and CNLC stage IIIa-IIIb patients; 7. Patients with expected survival >= 6 months; 8. Patients with an ECOG score of 0-1; 9. Patients should meet the following hematological indicators: platelet count >= 50 x 10^9/L; 10. Patients should meet the following biochemical indicators: creatinine clearance rate >= 60 ml/min; 11. Meet other indications for receiving radiation therapy.
Exclusion criteria
Exclusion criteria: 1. Patients who received PD-1, TACE and other treatments within 6 months before enrollment; 2. Patients with HIV infection, HCV infection, uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease or other diseases considered by the investigator to be excluded from the group; 3. Have other malignant tumors before or now; 4. Those with a history of bone marrow or organ transplantation; 5. Patients with secondary brain metastases; 6. Subjects suffering from immune deficiency diseases or autoimmune diseases; 7. Identify those who are allergic to or may be allergic to polygyri injection components; 8. Pregnant and lactating women; 9. Drug abuse, clinical or psychological or social factors affecting informed consent or the conduct of research; 10. Any uncertainties that have an impact on patient safety or compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Time to treatment remission;Duration of remission;Disease control rate;9-month survival rate;12-month survival rate;overall survival; | — |
Countries
China
Contacts
Public ContactJi Hongbing
Mengchao Hepatobiliary Hospital of Fujian Medical University
Outcome results
None listed