nasopharyngeal carcinoma
Conditions
Interventions
Treatment group:Camrelizumab and chemoradiotherapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in and sign the informed consent in person; 2. Aged 18-70 years, gender not limited; 3. Pathologically confirmed WHO type I, II or III nasopharyngeal squamous cell carcinoma at the time of initial treatment, WHO had received radical radiotherapy with at least half a year interval; 4. Patient staging rt3-4 /N+M0 (UICC/AJCC staging eighth edition); 5. Recurrence was confirmed by pathological examination or imaging examination, and the lesion was located in the nasopharyngeal and posterior pharyngeal lymph nodes, or the recurrent lesion of cervical lymph nodes that could not be operated on or remained after salvage surgery, and the patient refused surgery; 6. The patient can receive MRI examination, and the lesion can be evaluated (according to RECIST 1.1 standard); 7. Expected survival for at least 12 months; 8. ECOG score 0-1; 9. No serious hematopoietic function, abnormal heart, lung, liver, kidney and immune deficiency; Neutrophils >= 1.5*10^9/L; Hemoglobin >= 9g/dL; Platelet >= 100*10^9/L; Total bilirubin <= 1.5 times the upper limit of normal value; AST (SGOT) and ALT (SGPT) <= 2.5 times the upper limit of normal value; Creatinine <= 1.5 times the upper limit of normal value. 10. Subjects with active, known, or suspected autoimmune diseases. Patients with type 1 diabetes, hypothyroidism requiring hormone replacement therapy, skin conditions that require no systemic treatment (e.g., vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of external triggers, can be enrolled.
Exclusion criteria
Exclusion criteria: 1. A history of malignant tumor or multiple primary tumors (except basal cell carcinoma of the skin); 2. Complications can affect the safety of treatment, such as severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, and severe chronic heart disease. 3. After diagnosis of recurrence (prior to enrolling in the study), the patients received other local or systemic treatments. 4. Positive pregnancy test for women of childbearing age; 5. Uncontrolled active infection. 6. A known history of positive testing for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (AIDS); Untreated active hepatitis (hepatitis b: HBsAg positive with HBV DNA >= 500IU/mL; Hepatitis c: HCV RNA positive and abnormal liver function); Co-infection with hepatitis b and c; 7. Previously treated with an anti-tumor vaccine or other immunostimulant anti-tumor drug; 8. Previously treated with anti-pd-1 antibody, anti-pd-l1 antibody, anti-pd-l2 antibody, anti-cd137 antibody or anti-ctla-4 antibody (including ipilimumab or any other antibody or drug specifically acting on the T cell synergistic stimulation or checkpoint pathway.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DMFS;2 year OS; | — |
Countries
China
Contacts
Public ContactChaosu Hu
Fudan University Shanghai Cancer Center
Outcome results
None listed