Nasopharyngeal Carcinoma
Conditions
Interventions
trial group:Sintilimab combined with Gemcitabine plus Cisplatin
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. Pathologically confirmed WHO type II or III recurrent nasopharyngeal carcinoma; 2. Not suitable for local treatment, mainly referring to anti-tumor treatment, including surgery and radiotherapy: a. Not suitable for surgery: Nasopharynx: the tumor invades the deep side of parapharyngeal space, the musculus pterygoideus lateralis, the sinuses, the skull base (except the footwall of the sphenoid sinus), the intracranial or internal carotid artery; When the distance between the tumor and the internal carotid artery is less than 1cm, sufficient tumor resection margins cannot be guaranteed. Cervical lymph node: tumor infiltration of cervical spine, brachial plexus nerve, internal carotid artery; When the distance between the tumor and the internal carotid artery is less than 1cm, sufficient tumor resection margins cannot be guaranteed. b. Not suitable for radiotherapy: the recurrence time is less than 12 months from the end of the first radiotherapy; Patients with recurrent nasopharyngeal and necrosis; Tumor invasion of cavernous sinus, carotid sheath area or associated with internal carotid aneurysm; Recurrent cervical lymph node infiltration or encircling the internal carotid artery; Patients who cannot tolerate or refuse secondary radiation therapy; 3. Life expectancy >= 12 weeks; 4. Initial treatment adopted radical radiotherapy with or without chemotherapy; 5. Without the history of the other malignancy; 6. Aged 18–70 years old regardless of sex; 7. For hepatitis B (HBsAg positive) patients, HBV DNA = 70; 9. Female of child bearing potential, a negative urine or serum pregnancy test result within 7 days before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 6 months after the last dose of Sintilimab; 10. Normal renal and hepatic function: ALT and AST = 60 mL/min; Adequate bone marrow function: absolute white blood cell count >= 4.0 * 10^9/L, neutrophil >= 2.0 * 10^9/L, hemoglobin >= 90 g/L, platelets >= 100 * 10^9/L); 11. Written informed consent with exact date obtained from the individual patients before certain proposed step.
Exclusion criteria
Exclusion criteria: 1. Detection of distant metastasis before treatment; 2. Allergy to monoclonal antibodies or any compound of study therapy; 3. Prior therapy with an anti-PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent; 4. Following conditions within 4 weeks before enrollment: underwent major surgery, had a history of serious trauma; 5. Have known autoimmune diseases, except the following two cases: (1) patients with autoimmune-related hypothyroidism receiving stable doses of thyroid hormone; (2) patients with type 1 diabetes receiving stable insulin treatment regimen; 6. Received systemic immunostimulatory drugs (including but not limited to interferon or IL-2) within 4 weeks before enrollment or 5 half-lives of the drug; 7. Concurrent medical condition requiring the use of cortisol ( > 10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except the following: inhalation or topical corticosteroids; 8. Previous bone marrow transplantation or organ transplantation; 9. Idiopathic pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, idiopathic pneumonia or other active pneumonia; 10. Received a live vaccine within 4 weeks of enrollment; 11. Active infection, including Hepatitis B (HBsAg + and HBV-DNA >= 1000copies/mL), Hepatitis C or Human Immunodeficiency Virus (HIV) infection (HIV antibody +); 12. Had poor treatment compliance because of mental or other basic diseases; 13. Pregnancy or breast feeding; 14. Uncontrolled cardiovascular disease: New York Heart Association (NYHA) class 3 or 4, myocardial infarction within a year, unstable angina, supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; 15. Patients unable to be followed up regularly; 16. Accompanied by serious uncontrollable infection or medical diseases; 17. Inadequate organ function; 18. Laboratory examination: total bilirubin > upper limit of normal (ULN); AST and (or) ALT > 1.5 * ULN and ALP > 2.5 * ULN; 19. Conditions that may adversely affect pharmacokinetics: such as psychiatric disorders, central nervous system disorders, chronic diarrhea, ascites and hydrothorax; 20. Suffered from an additional malignancy within the last 5 years, with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in-situ cervical.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Drug safety;Quality of Life; | — |
Countries
China
Contacts
Public ContactGuo Xiang
Department of Nasopharyngeal Carcinoma, Cancer Center, Sun Yat-Sen University
Outcome results
None listed