nasopharyngeal carcinoma
Conditions
Interventions
experimental group:Cetuximab combined with docetaxel/cisplatin as first-line induction therapy, and capecitabine maintenance therapy
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Between 18 and 75 years old, there is no restriction on men and women; 2) Diagnosed as NPC by histopathological or cytological examination; 3) Newly treated metastatic NPC; or after radical radiotherapy, recurrence in the non-radiotherapy field accompanied by distant metastasis; or after radical radiotherapy, recurrence in the radiotherapy field Accompanied by distant metastasis, and the recurrence time is more than one year; Patients who relapse after the above radical treatment have not received EGFR monoclonal antibody or/and paclitaxel before (except those who have received Docetaxel or Paclitaxel but have not used albumin-coated paclitaxel) 4) There must be at least one measurable lesion (according to RECIST 1.1); 5) ECOG PS: 0 or 1; 6) Expected survival time >= 6 months; 7) Laboratory inspection meets the following standards: Bone marrow function: absolute count of blood neutrophils (ANC)>= 1.5x10^9/L; platelets (PLT)>= 80x10^9/L; hemoglobin (HB)>= 90g/L; Liver function: serum total bilirubin (STB), combined bilirubin (CB) <= upper limit of normal (ULN) x 1.5; alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= ULN x 2.5 (when there is no liver metastasis); or <= ULN x 5 (when there is liver metastasis); Kidney function: creatinine (Cr) <= ULN; coagulation function: prothrombin time (PT) international normalized ratio (INR) <= ULN x 1.5; 8) Female: contraception during the treatment and within 6 months after the end; non-lactating period; men: contraception during the treatment and within 6 months after the end; 9) The patient voluntarily and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those who have received radiotherapy or surgery on the target lesion before enrollment; 2) Receive SFDA approved immunotherapy with anti-NPC indications within 2 weeks before enrollment therapy or Chinese medicine treatment; 3) When the clinical symptoms and signs suspect brain metastasis, head MRI should be performed, if brain metastases are found, they cannot be included in the group; 4) Those who have malignant tumors from other histological sources besides NPC; 5) Severe infections require intravenous antibiotic, antifungal or antiviral treatment; 6) Active tuberculosis; 7) Severe cardiovascular diseases, including high blood pressure, uncontrollable medical treatment Stable angina, history of myocardial infarction in the past 6 months, congestive heart failure > NYHA Class II, severe arrhythmia and pericardial effusion, etc.; 8) Suffer from mental illness and poor compliance; 9) Cases considered by the investigator to be inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Event-Free Survival, EFS;Event-Free Survival, EFS;Response Rate, RR;advance event; | — |
Countries
China
Contacts
Public ContactTongyu Lin
Sichuan Cancer Hospital
Outcome results
None listed