Study of PolyIC and PD-1 mAb in Subjects With Unresectable Hepatocellular Carcinoma

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Hepatocellular carcinoma, Polyinosinic-polycytidylic acid, PD-1 mAb Read More

Inclusion Criteria:

1. Hepatocellular carcinoma with imaging diagnosis, in barcelona stage C, or stage B but resistant/recurrent to prior local treatment (e.g., TACE).
2. Eastern cooperative oncology group physical fitness score: 0-2.
3. Predicted survival time≥3 months.
4. Liver function of Child-Pugh A-B, no hepatic encephalopathy or physical examined ascites.

5. Routine blood tests were in accordance with the following criteria:

   White blood cell (WBC)≥2.0x10^9/L, Neutrophil≥1.0x10^9/L, platelet (PLT)≥50x10^9/L, hemoglobin (HB)≥80 g/dL, creatinine≤1.5xULN (upper limit of normal value), Alanine transaminase (ALT) and aspartate aminotransferase (AST)≤5xULN, total bilirubin (TB)≤51.3umol/L, international normalized ratio (INR) or prothrombin time (PT)≤1.7xULN, activated partial thromboplastin time (APTT)≤1.5xULN, serum albumin≥28g/L

6. Patients will be informed consent, and understand and are willing to cooperate with the trial and sign related documents.

Exclusion Criteria:

1. Has a history of malignant tumor in last 2 years, except basal and skin squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, superficial bladder cancer and carcinoma in situ of breast.
2. Received the treatment of polyIC or immune checkpoint inhibitors (e.g., PD-1/PD-L1 mAb or CTLA-4 mAb) in last 2 years.
3. Received the therapies of multi-kinase inhibitors (e.g., sorafenib, regorafenib), systemic chemotherapy, local therapy (e.g., TACE, radiotherapy), vaccination, immunomodulating therapy （e.g., interleukins, thymosin） or any other clinical trial in last 4 weeks.
4. Received any corticosterone or immunosuppressive drug in last 2 weeks.
5. Toxicity induced by previous anti-tumor therapies has not returned to the status of baseline or stability.
6. HIV positive (including previous anti-retroviral therapy), active HCV infection or active syphilis.
7. Any severe liver disease (e.g., severe liver cirrhosis, severe liver adenoma)
8. Any active or recurrent autoimmune disease.
9. Any interstitial pneumonia, non-infectious pneumonia, or uncontrolled systemic disease (e.g., uncontrolled hypertension or diabetes).
10. Severe cardiovascular risk factors.
11. Has a history of allogeneic stem cell transplantation or organ transplantation.
12. Imaging confirmed brain or meninges metastases.
13. Has the plan of pregnancy, or lactation.
14. Any kind of psychiatric disease or laboratory test abnormality that may result in the subject's failure to fully comply with the laboratory protocol.