| Eligibility |
Inclusion Criteria:
1. Patients have histologically confirmed hypopharyngeal squamous cell carcinoma and
require total laryngectomy, including the piriform fossa, postcricoid region, and
posterior pharyngeal wall with TNM stage cT3-4aN0-2M0(AJCC 7th).
2. Able to understand and willing to sign a written informed consent document.
3. Age= 18 and= 70 years.
4. Male or female.
5. Performance status of ECOG 0-2.
6. Expected lifetime > 6 months.
7. Normal blood test, hepatic and renal functions. Normal hearing. Blood test:
WBC=4.0×109/L,ANC=2.0×109/L,PLT=100×109/L,HGB=100g/L;Hepatic function: ALT?AST< upper
limit of normal. Kidney function: Serum creatinine < upper limit of normal value, and
creatinine clearance rate = 60 ml/min(Cockcroft-Gault formula). Cardiac
ultrasonography left ventricular ejection fraction >50%.
8. No prior allergic reaction to biological agents and/or ingredient in the drug.
9. No drug abuse.
10. Good compliance.
11. No other important related diseases (such as other tumors, severe heart, lung and
central nervous system diseases, etc.).
12. Negative pregnancy test (for female patients with fertility).
13. Male patients with fertility and female patients with fertility and pregnancy risk
must agree to use contraceptive methods throughout the study period, and continued
until at least 6 months after the last dose of cisplatin and 30 days after the last
dose of PD-1 antibody/placebo (whichever occurs later). Female patients who do not
have fertility (ie meet at least one of the following criteria): Have undergone
hysterectomy and/or bilateral oophorectomy with archival records, medically confirmed
ovarian function decline; In postmenopausal state. It is defined as: At least 12
months of continuous menstruation without other pathological or physiological reasons,
and the status confirmed by serum follicle stimulating hormone (FSH) levels is
consistent with postmenopausal status.
Exclusion Criteria:
1. Patients with cervical lymph node cN3.
2. Have a history of other cancers in the past five years, radical or untreated prostate
cancer (Gleason score = 6), or complete treatment of breast ductal carcinoma in situ,
except for patients with cured skin basal cell carcinoma or squamous cell skin cancer.
3. Patients with target lesions who have received radiation therapy or surgery (except
biopsy).
4. Patients who have previously used chemotherapy, immunotherapy, or biological targeted
therapy for primary tumors
5. Patients who have participated in other clinical trials within 4 weeks before the
test.
6. Any of the following conditions in the first 6 months of random grouping: myocardial
infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident, patients with
transient ischemic attack or symptomatic pulmonary embolism.
7. Patients with hypertension who cannot control well through single antihypertensive
medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg);
8. Patients with grade I or above coronary heart disease, arrhythmia (including men with
a QTc interval >450 ms, women >470 ms), and cardiac insufficiency.
9. Urinary protein was greater than ++ and 24-hour urinary protein quantification >1.0 g.
10. Many factors that affect oral medications (such as inability to swallow, nausea,
vomiting, chronic diarrhea, and intestinal obstruction).
11. Patients with abnormal coagulation function(INR>1.5?APTT>1.5 ULN)and bleeding
tendency.
12. Patients with a history of psychotropic substance abuse that is active or has a mental
disorder.
13. Patients who required systemic treatment with corticosteroids (>10 mg prednisone
equivalent daily) or other immunosuppressive agents within 2 weeks prior to the first
use of the study drug.
14. Patients with a history of severe allergies or allergies; patients with active
autoimmune diseases that may worsen when receiving immunostimulants; patients with
type 1 diabetes, vitiligo, psoriasis, or hypothyroidism or hyperthyroidism who do not
require immunosuppressive therapy are eligible to participate in the study.
15. Patients who have previously been diagnosed with immunodeficiency or known human
immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related
diseases. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV) surface
antigen is positive at screening, or patients with positive HCV RNA [ribonucleic acid]
when positive for anti-HCV antibody screening test.
16. Vaccination within 4 weeks prior to randomization, except for inactivated vaccines.
17. Pregnant or lactating women who are in the reproductive period but have not taken
effective contraceptive measures.
18. The investigator believes that it is inappropriate for individuals to participate in
the trial: having, for example, severe acute or chronic medical conditions (including
immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary
fibrosis) or mental illness (including recent time [within the past year] or active
suicidal ideation or behavior) .
19. With a history of tuberculosis or antituberculosis treatment.
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