Nasopharyngeal Carcinoma
Conditions
Interventions
Experimental group:Toripalimab combined with capecitabine
Sponsors
Department of Nasopharyngeal Carcinoma, Cancer Center, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 18-70 years; 2.Patients with pathologically confirmed World Health Organisation (WHO) type II or type III nasopharyngeal carcinoma prior to primary treatment; 3.Patients initially treated with radiotherapy, chemoradiotherapy, or induction chemotherapy followed by chemoradiotherapy; 4.Patients with pathologically (biopsy or fine needle aspiration) or radiologically (at least two classic radiological features [with or without clinical symptoms] on CT, MRI, or PET-CT) diagnoses of persistent or residual nasopharyngeal carcinoma (nasopharyngeal tumours and/or neck lymph nodes) at 12–16 weeks after the completion of primary treatment; 5.Patients not suitable for local treatment, where local treatment mainly refers to methods related to anti-tumour therapy, including surgery and radiotherapy; 6.Patients with an expected survival of =12 weeks; 7.Patients with a Karnofsky Performance Scale (KPS) score =70; 8.Fertile female patients with a negative serum pregnancy test result at screening (within seven days prior to the first administration of the trial drug) and taking effective contraception before entry into the trial and throughout the trial until six months after the last administration of the trial drug; 9.Patients without serious dysfunctions of the heart, lung, liver, kidney, and other vital organs; 10.Patients with normal liver and kidney functions: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =1.5 times the upper limit of normal (ULN), total bilirubin =1.5 times the ULN; creatinine clearance rate =60 mL/min; adequate bone marrow function: leukocyte count >4.0×109/L, neutrophil count >2.0×109/L, haemoglobin level >90 g/L, platelet count >100×109/L; 11.Patients who sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with persistent or residual nasopharyngeal carcinoma who develop distant metastases prior to trial; 2.Patients with a history of allergic to toripalimab, any component of capecitabine, or other monoclonal antibodies; 3.Patients with prior treatments against the programmed cell death-1 (PD-1) receptor or its ligand PD-L1 or the cytotoxic T-lymphocyte-associated protein 4 (CTLA4) receptor, or received other immunotherapy; 4.Patients who received any anti-tumour therapy within 4 weeks prior to the trial, or underwent major surgery, or had a history of serious trauma (except for primary treatment for nasopharyngeal carcinoma); 5.Patients with a history of autoimmune disease, except for the following two types of patients after evaluation: (1) patients with autoimmune-associated hypothyroidism who are receiving stable doses of thyroid hormone replacement therapy; (2) patients with controlled type I diabetes mellitus on a stable insulin regimen; 6.Patients administered a systemic immunostimulatory drug (including but not limited to interferon or interleukin [IL]-2) within 4 weeks prior to the trial or within 5 half-lives of the drug, whichever is shorter; 7.Patients administered systemic corticosteroids (>10 mg/d prednisone or equivalent) or other systemic immunosuppressants within 2 weeks prior to the trial, except for patients using topical or inhaled corticosteroids; 8.Patients with a history of bone marrow or organ transplantation; 9.Patients with a history of idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, or idiopathic pneumonia, or with other active pneumonia; 10.Patients vaccinated within 4 weeks prior to the trial; 11.Patients with active infectious disease, including tuberculosis, hepatitis B (hepatitis B surface antigen [HBsAg]-positive), hepatitis C or AIDS (HIV antibody-positive); 12.Patients unable to comply with treatment due to mental or other underlying illnesses; 13.Female patients who are pregnant or lactation; 14.Patients with major cardiovascular disease: patients with class II or higher New York Heart Association (NYHA) functional classification, with myocardial infarction within 1 year, with unstable angina, with supraventricular tachycardia, or with ventricular arrhythmia requiring clinical intervention; 15.Patients unable to comply with regular follow-up visits for psychological, social, family, or geographical reasons; 16.Patients with severe uncontrollable infections or medical conditions; 17.Patients who suffer from major organ dysfunction such as decompensated cardiac, pulmonary, renal, or hepatic dysfunction and thereby are unable to tolerate treatment; 18.Patients with the following laboratory test results: total bilirubin >1.5 times the ULN; AST and/or ALT >1.5 times the ULN with alkaline phosphatase >2.5 times the ULN; 19.Patients with factors affecting drug administration, distribution, metabolism, and excretion, such as mental disorders, central nervous system disorders, chronic diarrhoea, ascites, and pleural fluid; 20.Patients with other prior or concurrent malignancies (except for cured malignancies with disease-free survival of >5 years [eg, basal cell carcinoma of the skin, carcinoma in situ of the cervix]); 21.Patients unwilling to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;Disease control rate;Duration of response;Progression-free survival;Safety profile;Treatment compliance; | — |
Countries
China
Contacts
Public ContactGuo Xiang
Department of Nasopharyngeal Carcinoma, Cancer Center, Sun Yat-sen University
Outcome results
None listed