Head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Three cycles of PD-1 monoclonal antibody plus neoadjuvant chemotherapy with gemcitabine and cisplatin
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Untreated patients with locally advanced squamous cell carcinoma of the head and neck confirmed by histology or cytology; 2. Patients judged by surgeons to be operable; 3. Patients aged from 18 to 70 years old; ECoG: 0-2 points; 5. Patients with an estimated survival time of more than 6 months; 6. According to RECIST 1.1, subjects with at least one measurable lesion; 7. The functions of main organs meet the following standards (no blood components or cell growth factors are allowed to be used within 14 days) (1) HB >= 90 g / L; Neutrophil ANC >= 1.5 x 109 /L Platelet count PLT >= 100 x 10^9 /L (2) Serum albumin >= 28g / L; (3) TBIL = 50 ml / min; (5) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 x ULN (for anticoagulant therapy with stable dose, such as low molecular weight heparin or warfarin, and INR can be selected within the expected treatment range of anticoagulant); (6) TSH <= ULN; If the level of T3 and T4 is abnormal, the patients with normal level of T3 and T4 can be selected; 8. Women of childbearing age should agree to use contraceptive measures (such as intrauterine device, contraceptive or condom) during and within 3 months after medication; The patients with negative serum or urine pregnancy test within 7 days before the study, who must be non lactation patients, and men should agree to use contraceptives during the study period and within 3 months after the end of the study period; 9. The subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients who had a history of allergy to PD-1 mAb, gemcitabine or cisplatin; 3. Patients with a history of other malignant tumors in the past 5 years or at the same time, except the cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid; 4. Patients with uncontrollable cardiac clinical symptoms or diseases, such as: (1) Heart failure above NYHA grade II; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinical supraventricular or ventricular arrhythmias requiring clinical intervention; 5. Subjects who have received any of the following treatments: (1) Received any research drug before the first use of the research drug; (2) At the same time, another clinical study was enrolled, unless it was an observational (non intervention) clinical study or a follow-up intervention of a new clinical study; (3) Subjects requiring systemic treatment with corticosteroids (more than 10 mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks before the first use of the study drug, except for the use of corticosteroids for local inflammation and prevention of allergy, nausea and vomiting. In the absence of active autoimmune diseases, inhaled or topical corticosteroids and corticosteroids with a dose greater than 10 mg prednisone per day are allowed; (4) Had been vaccinated with anti-tumor vaccine or had been vaccinated with live vaccine within 4 weeks before the first administration of the research drug; (5) Major surgery or severe trauma within 4 weeks before the first use of the study drug; (6) Left ventricular ejection fraction (LVEF) was more than or equal to 60%; 6. Subjects with severe infection (CTC AE greater than grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc; Baseline chest imaging revealed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral or intravenous antibiotics (excluding prophylactic use of antibiotics); 7. Patients with active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone; Use stable insulin in type 1 diabetes. It does not include patients with vitiligo or recovered childhood asthma / allergy who do not need any intervention in adulthood; 8. Patients with history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or bone marrow transplantation; 9. Subjects with active pulmonary tuberculosis infection found by medical history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active pulmonary tuberculosis infection history 1 year before enrollment but without regular treatment; 10. Active hepatitis (HBV DNA >= 2000 IU / ml or 10; 000 copies / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method) 11. Known history of psychotropic drug abuse, alcoholism and drug abuse; 12. Patients with symptomatic brain met
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response, MMR;Objective Response Rate, ORR;complete resection;pathologic complete response, pCR; | — |
Countries
China
Contacts
Public ContactZhigang Liu
The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed