Patients with locally advanced hypopharyngeal cancer
Conditions
Interventions
Experimental group:Two cycles of neoadjuvant therapy: Adalimumab 1200mg, intravenous infusion, Day 1, every 3 weeks
Albumin-based paclitaxel 260mg/m2, intravenous infus
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 years old to 70 years old, gender not restricted; 2. ECOG PS score: 0-1; 3. Patients who can undergo surgical resection and are willing to undergo it; 4. Hypopharyngeal cancer diagnosed by histological/cytological and imaging methods, with clinical stage of T1-2N1-3 or T3-4 any N; 5. At least one measurable lesion (according to RECIST 1.1 standard); 6. Expected survival period of at least 12 weeks; 7. Good functions of other major organs (liver, kidney, hematological system, etc.): - Hemoglobin >= 90g/L (no blood transfusion, no use of hematopoietic factors and no use of drugs to correct within 2 weeks before the first administration); 1.- Absolute neutrophil count (ANC) >= 1.5×10^9/L; 2.- Platelet count >= 100×10^9/L; 3.- Total bilirubin = 60ml/min; 6.- For patients who have not received anticoagulant treatment, the international normalized ratio (INR) of prothrombin time <= 1.5, and activated partial thromboplastin time (APTT) <= 1.5 times the upper limit of normal value. 8. Female subjects with reproductive capacity must undergo a pregnancy test (serum or urine) within 72 hours before starting the study medication (negative result), and are willing to use a medically approved highly effective contraceptive method (such as intrauterine device, contraceptive pills or condoms) during the study period and within 90 days after the last administration of the study drug; 7.For male subjects whose partners are of reproductive age, they must agree to use an effective method of contraception or undergo surgical sterilization during the study period and within 90 days after the last administration of the study drug; 9. No history of allergy to related drug components; 10. Subjects voluntarily join this clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Has received any anti-tumor treatment before, including radiotherapy, chemotherapy, targeted therapy, immunotherapy, and traditional Chinese medicine anti-tumor treatment (except for the treatment of malignant tumors that were cured and without recurrence or metastasis for >= 5 years in the past); 2. Has undergone surgical treatment for the primary tumor or lymph nodes before; 3. Has suffered from any malignant tumor in the past 5 years (excluding cured skin basal cell carcinoma or cervical carcinoma in situ); 4. Has distant metastasis; 5. Has any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (including those that can be included after hormone replacement therapy), pulmonary tuberculosis), has completely recovered childhood asthma and does not require any intervention or systemic treatment after adulthood, and has skin diseases such as vitiligo, psoriasis or alopecia that can be included (patients requiring bronchodilator medical intervention are not included); 6. Within 2 weeks before the first administration, has used corticosteroids (> 10 mg/day prednisone or other equivalent hormones) or other immunosuppressants for systemic treatment. In the absence of active autoimmune disease, inhalation or local use of corticosteroids, and adrenal hormone replacement therapy with a dose of = 140 mmHg or diastolic blood pressure >= 90 mmHg); 1.or has grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval for males >= 450 ms, females >= 470 ms); 2.according to NYHA standards, III-IV grade heart function impairment, or echocardiography indicating left ventricular ejection fraction (LVEF) = (++), or 24-hour urine protein quantity >= 1 g or severe liver and kidney dysfunction; 11. Allergic to the test drug; 12. Known human immunodeficiency virus (HIV) infection; 13. Pregnant or lactating women; 3.subjects with reproductive capacity who are unwilling or unable to take effective contraceptive measures; 14. Have neurological or mental disorders and cannot cooperate; 15. Other situations deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate, MPR;Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactWu Sangang
The First Affiliated Hospital of Xiamen University
Outcome results
None listed