Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.

Korábbi kezelés

• Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
• Any agents which could affect the absorption or pharmacokinetics of the study drugs

Más betegség

• Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
• Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
• Patients accompanied with other tumors or past medical history of malignancy;
• Allergic to contrast agent;
• Other conditions that investigator decides not suitable for the trial.

Laborértékek

• Patients have poor compliance. A.Impaired clotting test (platelet count < 60000/mm3, prothrombin activity < 50%).
  • B.Renal failure / insufficiency requiring hemo-or peritoneal dialysis. C.Known severe atheromatosis. D.Known uncontrolled blood hypertension (> 160/100 mm/Hg).

Egyéb

• Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;

• Histologically or cytologically confirmed previously untreated hepatocellular carcinoma (HCC). If a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected HCC are eligible, but pathology must be confirmed prior to initiating treatment on study.
• The patient must be a suitable candidate for surgery, in the opinion of the treating physician.
• Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation.
• Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
• Absolute neutrophil count (ANC) >= 1.5 x 10\^9/L; Hemoglobin >= 8.0 g/dL; Platelets >= 100 x 10\^9/L; Total bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL); Creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 mL/min using Cockcroft-Gault formula for creatinine clearance calculation OR 24-hour urine creatinine clearance >= 50 mL/min.
• Birth control.
• Willing and able to comply with scheduled visits, treatment plan and laboratory tests.