Refractory head and neck tumors
Conditions
Interventions
Treatment group:Hypofractionated radiotherapy combined with PD-1 inhibitor and GM-CSF (Tellix) in the treatment of refractory head and neck tumors
Sponsors
The First Affiliated Hospital of the Military Medical University of the PLA Air Force
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. Patients with head and neck squamous cell carcinoma recurrence after receiving standard first-line and second-line treatment; 3. Head and neck malignancies (e.g. adenoid cystadenocarcinoma, lung metastasis, sarcoma, etc.) without the standard treatment for recurrence/metastasis recommended by guidelines; 4. At least one measurable lesion with >=1cm; 5. ECOG score 0-2 with survival time>=3 months; 6. More than 1 year interval between radical radiotherapy and recurrence. 7. One week before enrollment, the organ function level reached the following standards: 1) Bone marrow function: hemoglobin >=80g/L, white blood cell count >=3.5*10^9/L or neutrophil count >=1.5*10^9/L, platelet count >=100*10^9/L, CD8+T lymphocyte absolute value >=200/uL; 2) Liver: serum total bilirubin level 1.5 times the normal upper limit, direct bilirubin level must =50ml/min, urea nitrogen =30g/L; 8. Patients with heart or lung dysfunction could enroll in this study if these underlying disease were evaluated specialist doctor; 9. The patient must sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. patients with pregnancy and lactation. 2. Patients with a history of malignant diseases in the last 5 years, except for cured skin cancer and cervical carcinoma in situ. 3. Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as determined by the investigator, may prevent the signing of informed consent or affect the patient's compliance with medication. 4. Patients with organ transplantation. 5. patients with systemic infections, or serious disorders of blood, kidney, metabolism, gastrointestinal, endocrine or metabolic system, or other serious uncontrolled concomitant diseases; 6. patients with allergic reaction to any ingredient of investigating drugs. 7. People with a history of immunodeficiency, including HIV or other immune-related diseases requiring long-term hormone therapy. 8. patients with acute or chronic tuberculosis infection. 9. Patients receiving TCM treatment within 1 month; 10.Patients with other potential conditions which are unsuitable for study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, Progression-Free-Survival;Disease Control Rate, DCR;Duration of Response, DOR; | — |
Countries
China
Contacts
Public ContactMei Shi
Department of Radiation Oncology, The First Affiliated Hospital of Airforce Medical University
Outcome results
None listed