hepatocellular carcinoma
Conditions
Interventions
TTPV group:TACE/HAIC+apatinib+karelizumab + Individualized neoantigen peptides vaccine
Sponsors
Mengchao Hepatobiliary Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patients should volunteer to join the trial and sign the informed consents; 2. Aged 18-70 years, male and female; 3. Patients with unresectable hepatocellular carcinoma or intrahepatic cholangiocarcinoma confirmed by CT/MRI or histological cytology (BCLC stage B-C or CNLC stage IIb, IIIa, IIIb); 4. The treatment plan is TACE/HAIC combined with apatinib and camrelizumab; 5. According to RECIST v1.1, the response evaluation standard for solid tumors, there is at least one lesion in the liver that can be measured by imaging; 6. Patients with expected survival >= 6 months; 7. Patients with an ECOG score of 0-1; 8. Patients were should meet the following criteria: Child-Pugh A or B (score of 7 or less), serum creatinine less than 1.5 times the upper limit of the normal; 9. Patients should meet the following hematological indicators: neutrophil count >= 1.5 x 10^9/L, hemoglobin >= 9 g/dL, platelet count >= 75 x 10^9/L; 10. Meet other indications for receiving TACE/HAIC combined with apatinib and camrelizumab therapy.
Exclusion criteria
Exclusion criteria: 1. Patients who had received antitumor therapy 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 metastasis; 6. Subjects suffering from immune deficiency diseases or autoimmune diseases; 7. Pregnant and lactating women; 8. Drug abuse, clinical or psychological or social factors affecting informed consent or the conduct of research; 9. Any uncertainties that have an impact on patient safety or compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, Progression-Free Survival;TTR, time to remission;DOR, Duration of Response;DCR, Disease Control Rate;percentage of 6-month Overall Survival (OS);9-month OS%;12-month OS%;OS; | — |
Countries
China
Contacts
Public ContactWuhua Guo
Mengchao Hepatobiliary Hospital of Fujian Medical University
Outcome results
None listed