Relapsed/Refractory head and neck tumors
Conditions
Interventions
R130 treatment Group:Every 7-14 days,1-2 mL recombinant type I herpes simplex virus R130 injection (concentration of 1 x 10^8 plaque-forming Units/mL,PFU/mL) will be injected intratumoral in patients
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with head and neck cancer clearly diagnosed by histology and/or cytology, without systematic metastasis, and failure of standard treatment; 2. Age 18 to 75 years; 3. No absolute or relative centasis contraindiction,have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral drug delivery; 4. No severe functinonal falure of heart, brain, liver, kidney and lung; 5. Subjects with ECOG score of 0-2, and expected survival of 3 months or more; 6. No evidence of clinically significant immunosuppression; 7. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function during the screening period: White Blood Cell (WBC) >= 3.0 x 10^9/L; Absolute Lymphocyte Count (ANC) >= 1.5 x 10^9/L; Platelet >= 100 x 10^9/L; Prothrombin time (PT) or activated Partial; Thromboplastin Time (APTT) <= 1.5 x ULN; Serum Creatinine (Scr) <= 1.5 x ULN; Alanine aminotransferase (AST/ALT) <= 3 x ULN; Total Bilirubin(TBIL) <= 1.5 x ULN; 8. Be able to understand and sign the informed consent document; 9. Be able to stick to follow-up visit plan and other requirements in the agreement.
Exclusion criteria
Exclusion criteria: 1. With a history of allergy to similar drugs; 2. With hematological diseases, malignant tumors of the central nervous system, or combined with other malignant tumors; 3. Pregnancy, breast feeding; 4. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance; 5. Impaired function of important organs or a history of organ transplantation; 6. Receiving antiherpes simplex virus therapy such as acyclovir, ganciclovir, vancomycin, and acepromazine within 4 weeks, have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose; 7. Have had any serious adverse reactions associated with immunotherapy and have not recovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy; 8. Subjects with any severe and/or uncontrolled disease, including: poorly controlled hypertension (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); suffering from class I or higher myocardial ischemia or myocardial infarction, arrhythmia (QTc >= 470 ms and >= grade 2 congestive heart failure (New York Heart Association (NYHA) classification); active or uncontrolled severe infection (>= CTCAE grade 2 infection); Patients with previous organ transplantation, bone marrow transplantation (hematopoietic stem cell transplantation) and severe immune deficiency; Urine routine suggesting urine protein >= ++ and confirmed 24-hour urine protein quantification > 1.0 g; 9. Patients with past history of type I diabetes mellitus; 10. Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy; 11. Patients with active bleeding or severe coagulation dysfunction; 12. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Disease Control Rate, DCR;Duration of Response, DOR;overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical efficacy evaluation (CR, PR, SD, PD);Change of life quality; | — |
Countries
China
Contacts
Public ContactHaitao Wu/Jian Chen
Eye & ENT Hospital of Fudan University
Outcome results
None listed