recurrent or metastatic nasopharyngeal carcinoma
Conditions
Interventions
observation group:dosage regime:PF+Apatinib
Control group:PF protocol
Sponsors
the First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The first diagnosis of patients with advanced nasopharyngeal carcinoma or recurrent nasopharyngeal carcinoma patients treated with radiation and chemotherapy, and patients are not suitable for local treatment (mainly refers to the measures of anti-tumor treatment, including surgery, radiofrequency ablation, via hepatic artery chemotherapy embolism (conventional), radiation [except for patients with bone metastases, to relieve symptoms using local appropriate dose of the radiation does not affect the blood picture]) 2. Nasopharyngeal carcinoma clearly diagnosed by histology and cytology; 3. Male or female patients aged >18 years; 4. At least 6 months from the last treatment (radiotherapy or chemotherapy) before enrollment, including patients who have used platinum-containing regimens (such as PF regimens) but failed to develop new metastatic lesions; 5. At least one measurable lesion: CT and MRI have at least one diameter (maximum diameter) 10mm that can be accurately measured;Tumor lesions located in the original radiation field were not selected as measurable lesions; 6. ECOG PS score: 0-1; Adequate bone marrow function: peripheral blood leukocyte >4.0*10^9/L; neutrophil >2.0*10^9/L; hemoglobin >90g/L; platelet >100*10^9/L; Normal liver and kidney function: AST and ALT < 2.5 times normal upper limit (liver metastasis can be relaxed to 5 times normal upper limit); total bilirubin < 1.5 times the normal upper limit; creatinine clearance 60mL/min; 9. Life expectancy over 12 weeks; 10. Subjects voluntarily participated in this study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. The patient is eligible for topical treatment or the investigator plans to administer topical treatment prior to progression; 2. Clinical severe infection (> grade 2 nci-ctc V3.0); 3. Central nervous system metastasis occurred in the patient; 4. The patient's physical condition is life threatening; Pregnant or lactating patients; 5. a blood pregnancy test must be conducted on a fertile female subject within 7 days of the start of treatment, and the negative result can be continued; both men and women will be required to use contraceptives during the study period up to two weeks after the completion of the study; 6. ECOG PS score 2; 7. Patients with a history of peripheral neurological diseases (NCI CTC AE3.0 level 2); 8. Having other serious diseases at the same time; 9. Patients who have had or are currently infected with a tumor whose primary site or histology is different from the tumor evaluated in this study (except cervical carcinoma in situ, cured basal cell carcinoma, bladder surface tumor, or any tumor that has been cured more than 3 years since the study was enrolled); 10. The investigators considered inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR; | — |
Contacts
Public ContactKai Hu
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed