Efficacy and Safety of Toripalimab Combined With AP-induced Chemotherapy Followed in Non-metastatic IVB Hypopharyngeal Cancer

Inclusion Criteria:

1. Age 18 to 70 years old
2. The clinical stage was Ivb stage (AJCC 8th edition),
3. ECOG score was 0-1
4. Have not received any anti-tumor therapy such as radiotherapy, chemotherapy,immunotherapy or biological therapy
5. No contraindications of chemotherapy, immunotherapy and radiotherapy
6. The functional level of major organs conforms to the following criteria: 1) thestandard of blood routine examination should meet the following criteria: WBC ≥ 3.0x109, G-CSF and other hematopoietic stimulating factors. 2) biochemical testsshould meet the following criteria: TBIL ≤ 2.0 × ULN,ALT, AST ≤ 2.5 × ULN,BUN and CRE ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);

3. good coagulation function: defined as international standardized ratio (INR) orprothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulanttherapy, as long as PT is within the range of anticoagulant use. 4) Myocardialzymogram is within the range of normal value;

7. Women of childbearing age must have taken reliable contraceptive measures, orconducted pregnancy tests (serum or urine) within 7 days before admission, and theresults were negative, and were willing to use effective methods of contraceptionduring the trial period and within 2 months after the last administration of anti-PD-1antibody. For male subjects whose partners are women of childbearing age, effectivemethods of contraception should be used during the trial and within 2 months after thelast administration of anti-PD-1 antibody. 8. The subjects voluntarily joined thestudy, signed the informed consent form, had good compliance and cooperated withfollow-up.

Exclusion Criteria:

1. Previous or simultaneous suffering from other uncured malignant tumors, except curedbasal cell carcinoma of the skin, carcinoma in situ of the cervix and superficialbladder cancer
2. Patients with hypopharyngeal necrosis at the same time with the risk of bleeding.
3. Suffer from any active autoimmune disease or have a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis,myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included when hormonereplacement therapy is normal). Patients with vitiligo or asthma who have beencompletely relieved in childhood and can be included after adulthood without anyintervention, and asthma patients who need bronchodilators for medical interventioncan not be included.
4. Suffering from uncontrolled cardiovascular disease: myocardial ischemia or myocardialinfarction of grade Ⅱ or above, poorly controlled arrhythmias (including QTc interval ≥ 470ms); cardiac insufficiency of grade Ⅲ ~ IV according to NYHA criteria, or leftventricular ejection fraction (LVEF) < 50% indicated by color Doppler ultrasound;myocardial infarction occurred within 1 year.
5. There is an active infection or an unexplained fever occurs during the screeningperiod and before the first administration of the drug > 38.5 ℃ (according to theresearchers, the fever caused by the tumor can be included in the group).
6. Suffer from congenital or acquired immune deficiency (such as HIV infection), activehepatitis B (HBV-DNA ≥ 104copies / ml) or hepatitis C (hepatitis C antibody positiveand HCR-RNA higher than the lower limit of detection by analytical method).
7. Have previously received other PD-1 antibody therapy or other immunotherapy forPD-1/PD-L1.
8. Known to be allergic to paclitaxel, cisplatin, macromolecular protein preparations, orany anti-PD-1 antibody component.
9. If the subject has undergone a major operation, the toxic reactions and / orcomplications caused by the surgical intervention must be fully recovered beforestarting the treatment.
10. Within 4 weeks before the first use of research drugs (subjects who have entered thefollow-up period are calculated on the basis of their last use of experimental drugsor devices) or are participating in other clinical studies.
11. Live vaccine and COVID-19 vaccine are given within 4 weeks before the first use of thestudy; inactivated virus vaccine for seasonal influenza is allowed; live attenuatedinfluenza vaccine for nasal use is not allowed.
12. Pregnant or lactating women.
13. The researchers determined that the subjects had other factors that might force themto stop the study, such as other serious illnesses (including mental illness)requiring combined treatment, seriously abnormal laboratory tests, family or socialfactors, which may affect the safety of the subjects or the collection of trial data.