advanced recurrent metastatic head and neck tumours
Conditions
Interventions
Experimental group:HDRT+LDRT+PD-1 inhibit+GM-CSF
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. The patient had recurrent or metastatic advanced head and neck malignancies (including nasopharyngeal malignancies), had clear pathological diagnosis, imaging diagnosis and medical history, had no clear recommended standard treatment regimen or could not tolerate standard treatment regimen, and had clear measurable lesions (> 1cm); 3. For patients with squamous cell carcinoma progressing after first-line anti-tumor therapy, the treatment regimen must include a platinum-containing combination chemotherapy or platinum-based concurrent chemoradiotherapy, and patients with secondary drug resistance after previous anti-PD-1 /L1 therapy can also be included in the group; 4. There is no standard protocol recommended by guidelines for non-squamous cell carcinoma patients after first-line treatment failure (such as adenoid cystadenocarcinoma lung metastasis, sarcoma, etc.); 5. At least one lesion with a diameter of 1cm-5cm (metastasis >=1cm; if the patient has a relatively large metastasis, partial tumor irradiation can be allowed) can be treated with 16-24Gy/2-3Fx; Lymph node can be used as an independent measurable lesion (if lymph node is used as an evaluation lesion, it must meet the target lesion criteria, see RECIST1.1 for definition of lymph node target lesion); 6. Interval of more than 6 months after radical radiotherapy; Patients more than 6 months apart from previous radiotherapy; 7. No acute coronary syndrome or malignant arrhythmia occurred in the past 6 months; 8. ECOG(Eastern Cooperative Oncology Group), score 0-2, life expectancy assessment >=3 months; 9. No serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency in the past; 10. Ejection fraction of cardiac color ultrasound >=50%; 11. Myocardial enzyme profile and NT-proBNP should not exceed two times of the upper limit of normal value; 12. Troponin and CKMB values shall not exceed two times of the upper normal limit; 13. Patients who have developed atrioventricular block > grade 2 or above in the last six months and need to consider a pacemaker will not be included; 14. High blood pressure =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/µL; (2) Liver: serum total bilirubin level 1.5 times the normal upper limit, direct bilirubin level must =50ml/min, urea nitrogen =30g/L; 15. The patient must be capable of understanding and voluntarily signing informed consent.
Exclusion criteria
Exclusion criteria: 1. Single oligometastasis. 2. Pregnant or nursing patients. 3. Patients with a history of other malignant diseases in the last 5 years, except for cured skin cancer and cervical carcinoma in situ. 4. 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 adherence to medication. 5. Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, NYHA Class II or worse congestive heart failure, or severe arrhythmias requiring medical intervention, or a history of myocardial infarction within the last 12 months. 6. Immunosuppressive therapy is needed for organ transplantation. 7. Major active infections are known, or the presence of major blood, renal, metabolic, gastrointestinal, endocrine, or metabolic disorders as determined by the investigator, or other serious uncontrolled concomitant diseases. 8. Allergic to any investigational drug ingredient. 9. Patients with a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation, or other immune-related diseases requiring long-term oral hormone therapy. 10. In the period of acute and chronic tuberculosis infection (T-spot test positive, chest radiographs with suspicious tuberculosis lesions). 11. Other conditions deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxic reaction;Security;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactLi Xiangpan
Renmin Hospital of Wuhan University
Outcome results
None listed