| Eligibility |
Inclusion Criteria:
1. Male or female patients: 18-70 years old.
2. Pathologically diagnosed nasopharyngeal carcinoma.
3. Patients with nasopharyngeal carcinoma who have local recurrence after one
comprehensive treatment (clinical examination found definite local residual: clear
residual or cervical enlarged lymph node can be seen under electronic
nasopharyngoscope).
4. Patients with nasopharyngeal carcinoma who have distant metastasis after one
comprehensive treatment (found distant metastasis by liver ultrasound, chest X-ray,
bone scan or other examination (such as CT, MRI or PET/CT) as the clinician considers
appropriate.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Estimated survival =6 months.
7. The function of the main organs is good, that is, one week before joining the group,
the following requirements are met:
Blood routine examination:Hemoglobin > 80 g/L(no blood transfusion within 14
days);Neutrophils count > 1.5x10^9/L;Platelet count > 80x10^9/L; biochemical
test:serum total bilirubin =1.5×ULN(upper limit of normal), ALT or
AST=3×ULN;Endogenous creatinine clearance = 1.5×ULN;Acceptable clotting state: the
international standardized ratio ((INR)), prothrombin time (PT) and activated partial
thromboplastin time (APTT) of blood clots were less than 1.5 times of the upper limit
of normal (ULN).
8. All women with fertility potential must undergo a urine or serum pregnancy test during
screening and the results are negative.
9. The subjects voluntarily joined the study, signed the informed consent form, had good
compliance and cooperated with the follow-up.
Exclusion Criteria:
1. Before treatment, MRI showed that the tumor may have invaded important blood vessels
(such as enclosing the internal carotid artery / vein), or researchers have determined
that the tumor is highly likely to invade important blood vessels and cause fatal
massive bleeding during treatment.
2. There was a history of severe bleeding, and any bleeding events with a serious grade
of 3 or more in CTCAE4.0 occurred within 4 weeks before screening.
3. Patients with hypertension who cannot be well controlled by antihypertensive therapy
alone (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg); patients
with a history of unstable angina pectoris; patients newly diagnosed with angina
pectoris within 3 months or myocardial infarction within 6 months before screening;
arrhythmias (including QTcF: = 450ms in males, = 470ms in females) require long-term
use of antiarrhythmic drugs and New York Heart Association grade = II cardiac
insufficiency.
4. Positive urine protein.
5. Patients with abnormal blood coagulation and bleeding tendency (14 days before signing
informed consent: INR is within the normal range without anticoagulant); patients
treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or
their analogues; On the premise that the international standardized ratio of
prothrombin time ((INR)) is less than 1.5, low-dose warfarin (1mg orally, once a day)
or low-dose aspirin (daily dose not more than 100mg) is allowed for preventive
purposes.
6. Arteriovenous thrombosis occurred within one year before screening, such as
cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis
(except venous thrombosis caused by intravenous catheterization due to early
chemotherapy) and pulmonary embolism.
7. Long-term unhealed wound or incomplete fracture.
8. Any factors that affect the oral drug, such as inability to swallow, chronic diarrhea
and intestinal obstruction, etc.
9. For female subjects: women of childbearing age, it is not acceptable to use medically
approved contraception during the study treatment period and within 6 months after the
end of the study treatment period;Patients with positive serum or urine pregnancy
test;Nursing patients.Male subjects: patients who did not undergo surgical
sterilization or did not agree to use medically approved contraception during the
study and within 6 months after the study.
10. Having a history of psychotropic substance abuse and unable to quit or having mental
disorders.
11. Medical history of immunodeficiency, or other acquired, congenital immunodeficiency
disease, or history of organ transplantation.Any symptomatic autoimmune disease (such
as lupus, scleroderma, Crohn's disease, ulcerative colitis) that requires
administration of >10mg of prednisone equivalent. Lower dose steroids for conditions
such as hypophysitis are allowed.
12. Any serious harm to the subject's safety or evidence of significant medical illness
that in the investigator's judgment will substantially increase the risk associated
with the subject's participation in and completion of the study.
13. Any prior severe adverse event attributed to prior anti-PD1 therapy that, in the
Principal investigator's opinion, would contraindicate pembrolizumab administration
such as:Grade 2 or higher pneumonitis?Grade 4 AST or ALT elevation?Grade 3 or higher
colitis; Known active infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
or HIV. Cleared HBV/HCV infection is not an exclusion, nor is HIV infection with
cluster of differentiations 4 (CD4) counts >500 and an undetectable viral load.
14. Active bacterial, viral, or fungal infections, requiring systemic therapy apart from
anti-viral maintenance therapy for HIV;or Uncontrolled activity infected.
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