Nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:Gemcitabine plus cisplatin combined with anlotinib, toripalimab and stereotactic body radiotherapy
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Performance Status 0-1(ECOG); 2.Aged 18-65 years, male or non-pregnant women; 3.Pathologically confirmed non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated, WHO type II or III); 4.Stage IVB (8th AJCC/UICC stage), distant metastases found, but no recurrence of local lesions, and no previous systemic anti-tumor therapy for metastatic nasopharyngeal carcinoma. Metastatic lesions had to meet the following criteria: =4x10^9/L, Absolute neutrophil count (ANC) >= 1.5 x 10^9/ L, Hemoglobin >=90 g/L, Platelets count>=100x10^9/L; (2) Liver function: AST and ALT= 700 cm^3; (3) Renal function: Serum creatinine= 28g/L; (6) Urine protein =2+, only when urine protein quantification is =50%; 8.If pulmonary metastases are present, pulmonary function tests must be performed: expiratory volume per second (FEV1) >=1L; 9.Women must meet one of the following conditions: (1) Surgical sterilization; (2) Menopause for at least 1 year if menopausal; (3) For patients of childbearing potential, the following conditions must be met: A negative serum/urine pregnancy test prior to enrollment in the trial; agreement to use an approved method of contraception (e.g., oral, injectable, or implanted barrier method, spermicide and condom, or intrauterine device) that remains unchanged throughout the study period. Men must meet one of the following conditions: (1) Surgical sterilization: (2) An approved method of contraception must be used throughout the study and the method of contraception must be unchanged during the study period; 10.The patient has signed an informed consent form and is willing and able to comply with the study's planned visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1.Presence or current coexistence of other malignancies within 5 years, except for cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor-infiltrating basement membrane)]; 2.Patients who have received previous targeted drug therapy for VEGF; 3.Patients previously treated with immune control point (CTLA-4, PD-1, PD-L1, etc.) inhibitors; 4.Subjects with known hypersensitivity to any of gemcitabine, cisplatin, anlotinib, or toripalimab; 5.Previous metastatic lesions treated with radiotherapy; 6.Received systemic immunomodulator therapy (including but not limited to interferon, interleukin 2) within 28 days. 7.Subjects with central nervous system metastases; 8.There is a definite bleeding tendency or significant clinical bleeding symptoms within 28 days, including, but not limited to, gastrointestinal bleeding, nasal bleeding (excluding epistaxis and retracted snot blood), and persistent hemorrhagic disease or coagulation dysfunction; 9.A person who has coughing up blood or hemoptysis (defined as coughing up or hemoptysis of >=1 teaspoon of blood or small clots or coughing up blood without sputum) within 28 days, but blood in sputum is not excluded; 10.Imaging shows that the tumor wraps around important blood vessels or invades important blood vessels, or researchers judge that the tumor is likely to invade important blood vessels during treatment, which may lead to the risk of massive bleeding; 11.There were significant changes in the shape of the vertebral body (the height of the vertebral body was compressed >= 50%) or the vertebral body was unchanged but the volume of the dissolving bone was >= 50% and could lead to serious bone adverse events; 12.There were > 3 consecutive vertebral bodies involved; 13.Spinal cord compression has occurred; 14.The gap between tumor and spinal cord was less than 3mm; 15.Any of the following severe acute complications occurred before the participants entered the group (1) Unstable angina pectoris and/or congestive heart failure or vascular disease requiring hospitalization within 12 months (e.g. aortic aneurysm or peripheral venous thrombosis requiring surgical repair), or other heart damage judged by researchers that may affect the evaluation of drug safety (e.g. uncontrolled arrhythmia, myocardial infarction or ischemia); (2) Presence of esophagogastric fundus varices, unhealed ulcers, unhealed wounds or fractures within 6 months; (3) History of abdominal fistula, gastrointestinal perforation, intraperitoneal abscess or acute gastrointestinal bleeding within 6 months; (4) Presence of an arterial thromboembolic event within 6 months, venous thromboembolism NCICTCAE grade 3 or higher, transient ischemic attack (TIA), cerebral vascular accident (CVA), hypertensive crisis or hypertensive; (5) Encephalopathy Aggravated COPD (Chronic Obstructive Pulmonary Disease ,COPD) or other respiratory diseases requiring hospitalization within 28 days; (6) Active pulmonary infections and/or acute bacterial or fungal infections requiring intravenous antibiotic treatment within 28 days; (7) Presence of significant jaundice due to liver dysfunction within 7 days; (8) Minor surgery within 2 days (including catheterization, excluding central venipuncture via peripheral vein); (9) Patients with hypertension that are not well controlled by a single antihypertensive drug (systolic blood pressure >=160 mmHg dias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progress Free Survival;Duration of Response;Disease Control Rate;Adverse Event; | — |
Countries
China
Contacts
Public ContactKang Min
Guangxi Medical University
Outcome results
None listed