liver cancer
Conditions
Interventions
patients with hepatocellular carcinoma or metastatic hepatocellular carcinoma:Transarterial infusion of PD-1/PD-L1 mAb
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Subjects were required to meet the following inclusion criteria: 1. Grouping criteria for different cohorts: Cohort A: A. hepatocellular carcinoma diagnosed clinically or confirmed by histology or cytology according to the "diagnostic and treatment criteria for primary liver cancer" (Ministry of health, 2019 Edition). B. disease progression or adverse reactions can not be tolerated after at least one systematic treatment (targeted therapy and / or platinum based intravenous chemotherapy): chemotherapy includes FOLFOX (fluorouracil, folic acid and oxaliplatin) or any other platinum containing regimen; chemotherapy must be more than 2 cycles. Cohort B: A. metastatic hepatocellular carcinoma confirmed by pathology and clinical imaging. B. unresectable metastatic liver cancer. C. late patients with poor or intolerable systemic therapy. 2. Male or female, aged >= 18 years when signing ICF. 3. After receiving PD-1 / PD-L1 monoclonal antibody (single or combined use), the patient will progress later (need to exclude the situation of over progression). 4. The liver has at least one measurable target lesion (RECIST v1.1) if it is a progressive active lesion after local treatment (radiotherapy, ablation, TACE, etc.), the local treatment should be completed 4 weeks before the screening period imaging examination. 5. The patient can understand and be willing to sign the informed consent form. 6. The patient's ECoG score was 0 or 1. 7. The function of organ and blood system of the patient meets the requirements A. blood system function: absolute neutrophil count (ANC) >= 1.5 x 10^9 / L, platelet count >= 75 x 10^9 / L; B. sufficient renal function: serum creatinine 40 ml / min (Cockcroft Gault formula); C. liver function: total bilirubin <= 1.5 x ULN, AST and alt <= 5 x ULN; D. coagulation function: within the normal range of Pt time.
Exclusion criteria
Exclusion criteria: 1. It is known that allergy to PD-1 / PD-L1 antibody or drug-related Irae has occurred in the past. According to the guidelines for toxicity management related to inhibitors of CSCO immune checkpoint 2019, it meets the indication of permanent withdrawal. 2. There are known contraindications to percutaneous hepatic artery infusion. 3. The patient is currently receiving or has received irradiation or local treatment for the target lesion in the past 2 weeks. 4. The patient had undergone major surgical procedures (excluding biopsy) within 14 days before entering the study. 5. Have received or planned to receive car-t, vaccine and other immunotherapy. 6. The patient had metastatic encephalopathy, including asymptomatic and well controlled lesions. 7. Patients with malabsorption syndrome, diseases that significantly affect gastrointestinal function, gastrectomy or small bowel resection, or dysphagia and difficulty in retaining oral medication. 8. The patient has any clinically significant disease or history that the researcher believes may endanger the safety of the patient or the reliability of the study results. 9. The patient has a history of any other malignancies, unless the remission period is more than 1 year; skin cancer and cervical cancer in situ after radical treatment are not considered as exclusion criteria. 10. Female patients are pregnant or breastfeeding. 11. The patient had severe toxicity (>= ctcae5.0, grade 2) after previous use of another trial drug and / or previous cancer treatment, with the exception of anemia, fatigue and alopecia. 12. It is known that the HIV test results of the patients are positive, the presence of active hepatitis C, or the presence of hepatitis B infection and hepatitis B virus DNA more than 2000 IU / ml, or the presence of active hepatitis B and hepatitis C at the same time (the virus copy number is higher than the upper limit of detection). 13. The patient has a known history of drug addiction in the past year, which may lead to a high risk of non-compliance of the trial drug. 14. The patient had known active or suspected autoimmune diseases. Subjects who were allowed to be in a stable state and did not need systemic immunosuppressive therapy were allowed. 15. Subjects requiring systemic treatment with corticosteroids (> 10 mg / day prednisone efficacy dose) or other immunosuppressants within 14 days before administration of the study drug. In the absence of active autoimmune disease, inhaled or topical corticosteroids and prednisone dose > 10 mg / day are permitted for adrenal hormone replacement. 16. The baseline corrected QT interval QTc was > 450 ms, or the patient had known QT prolongation syndrome, torsade de pointes, symptomatic ventricular tachycardia, unstable cardiac syndrome within 3 months before screening visit, > grade 2 Nyca heart failure, > 2 The Canadian Cardiovascular association has angina pectoris or is receiving quinidine, procaine amine, propylamine, amiodarone, dronedarone, arsenic, dofetilide or sotalol methadone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DCR;ORR;AEs rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| DoR;PFS; | — |
Countries
China
Contacts
Public ContactMeng zhiqiang
Fudan University Shanghai Cancer Center
Outcome results
None listed