IT or IA Infusion of PD1/PDL1/CTLA4 Inhibitors Versus IV for Immunotherapy of Head/Neck Cancers (HNC)

Korábbi kezelés

• Patients participated in other 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

• 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 adriamycin chemotherapy drugs，contrast agent or lipiodol;

Laborértékek

• Patients have poor compliance.
  • Any contraindications for neck artery infusion procedure:
  • Impaired clotting test (platelet count < 60000/mm3, prothrombin activity < 50%).
  • 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;
• Subjects unable to suffer the discomfort of the artery infusion procedure

• Cytohistological confirmation is required for diagnosis of HNC.
• Signed informed consent before recruiting.
• Age between 18 to 80 years with estimated survival over 3 months.
• 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.
• Patients with advanced HNC which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection and other treatment.
• Birth control.
• Willing and able to comply with scheduled visits, treatment plan and laboratory tests.