local residual nasopharyngeal carcinoma after radiotherapy
Conditions
Interventions
Test group:nitituzumab plus capecitabine
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 70 years old; 2.Locally advanced NPC with radiographic residual lesions (according to RECIST 1.1 version) within 12 to 16 weeks after standard radical treatment regimen of platinum-containing chemoradiotherapy; 3.ECOG score of 0-1; 4.Laboratory and instrumentation tests that meet the following requirements: Blood routine: neutrophil count >= 1500/mm^3 (1.5 × 10^9/L) (no growth factors within 14 days); platelet count >= 100 000/mm^3 (100 × 10^9/L) (no corrective therapy within 7 days); haemoglobin >= 9.0 g/dL (90 g/L) (no corrective therapy within 7 days); Blood biochemistry: serum creatinine = 60 ml/min; total bilirubin = 50%; 5.Patients will voluntarily participate in the study and sign an informed consent form, and are expected to be compliant and able to cooperate with the study according to the requirements of the protocol; 6.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrolment and voluntarily use an appropriate method of contraception during the observation period and for 4 months after the last dose of study drug;
Exclusion criteria
Exclusion criteria: 1.Recurrent or distant metastatic NPC; 2.History of malignancy in the last 5 years (except for basal cell carcinoma or cervical carcinoma in situ); 3.Severe chronic or active infections require systemic antimicrobial, antifungal, or antiviral treatment, including tuberculosis infection; 4.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome, active hepatitis B (HBV DNA >= 1000 IU / ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of the assay) or co-infection with hepatitis B and hepatitis C; 5.Patients with untreated chronic hepatitis B or carriers of chronic B virus (HBV) with HBV DNA> 1000 IU / mL or patients with active hepatitis C virus (HCV) should be excluded. Note: Carriers of inactive hepatitis B surface antigen (HBsAg), treated and stable hepatitis B (HBV DNA =grade 2 persistent arrhythmia (according to NCI CTCAE 5.0 version), any level of atrial fibrillation, coronary / peripheral artery bypass, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or symptomatic pulmonary embolism; 8.Abnormal coagulation (INR> 1.5 or prothrombin time (PT)> ULN + 4 seconds or APTT> 1.5 ULN) with bleeding or thrombosis or on thrombolytic or anticoagulant therapy; 9.A history of severe hypersensitivity to nitituzumab, capecitabine, and / or any of the components thereof; 10.Patients with toxicity (due to prior anticancer therapy) not returning to baseline or stable, except for AEs not considered a possible safety risk (e. g., alopecia, neuropathy, and specific laboratory abnormalities); 11.Also participate in another therapeutic clinical study; 12.Patients with factors significantly affecting the absorption of oral drugs (eg, inability to swallow, chronic diarrhea, intestinal obstruction, etc.) were excluded; 13.Pregnant or lactating women; fertile patients who are unwilling or unable to take effective contraception; 14.Other conditions judged by the investigator that may affect the conduct of clinical studies and the determination of study results; 15.Rejection or inability to sign the informed consent form;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year local regional control rate, 2y-LRC;Relieve duration;2-years progression-free survival rate, 2y-PFS;2-years overall survival rate, 2y-OS;Quality of life score;Safety;Impact of tumour-related markers on prognosis; | — |
Countries
China
Contacts
Public ContactZheng He
The First Hospital of China Medical University
Outcome results
None listed