Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors

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.
  • Any contraindications for hepatic arterial infusion procedure:
  • 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;

• Cytohistological confirmation is required for diagnosis of cancer.
• Signed informed consent before recruiting.
• Age above 18 years with estimated survival over 3 months.
• Child-Pugh class A or B/Child score \> 7; ECOG score \< 2
• Tolerable coagulation function or reversible coagulation disorders
• Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L； PLT ≥50×10E9/L；INR \< 2.3 or PT \< 6 seconds above control；Cr ≤ 145.5 umul/L；Albumin \> 28 g/L；Total bilirubin \< 51 μmol/L
• At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
• Birth control.
• Willing and able to comply with scheduled visits, treatment plan and laboratory tests.