head and neck squamous cell carcinoma
Conditions
Interventions
treatment group:sintilimab 200mg ivgtt q21d + cisplatin 80mg/m2 ivgtt q21d,treatment for two cycles before operation
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) untreated and resectable stage II-IVa HPV+ and hpv-head and neck squamous cell carcinomas (including oral, oropharyngeal, hypopharyngeal and laryngeal cancers) diagnosed histologically and/or cytologically. 2) surgical resection is planned. 3) researchers believe that it can safely receive pd-1 monoclonal antibody combined with cisplatin neoadjuvant therapy. 4) aged >= 16 years. 5) ECOG 0 to 1. 6) measurable diseases defined by RECIST v1.1. 7) adequate bone marrow reserve and organ functions Bone marrow function Absolute neutrophils count (ANC) >= 1,000/ microliter (MCL) Platelets >= 75,000/ MCL Hemoglobin >= 8g/ dL, no blood transfusion or EPO dependence (within 7 days after assessment) Renal function Serum creatinine = 60mL/min > 1.5x mechanism ULN.(GFR can also be used in place of creatinine or CrCl). Creatinine clearance should be calculated according to institutional criteria. Liver function For subjects with a total bilirubin level of > of 1.5 ULN, serum total bilirubin 2.5 mg/dL condensation International standardized ratio (INR) or prothrombin time (PT) <= 1.5xuln, PT or PTT within the permitted range for anticoagulant use if subject receives anticoagulant therapy 8) women should agree to use contraceptive measures (such as intrauterine devices [iuds], birth control pills or condoms) during the study period and 6 months after the study;The serum or urine pregnancy test was negative within 7 days before study enrollment and must be non-lactation. Men should agree with patients who must use contraception during the study period and within 6 months of the end of the study period.
Exclusion criteria
Exclusion criteria: 1) previous anti-cancer monoclonal antibody (mAb) in patients who have received previous treatment with pd-1 monoclonal antibody or similar drugs did not recover from adverse events (i.e., 475 ms was screened. 14) the ejection fraction by 2D echocardiography (ECHO) during screening was < 40%. 15) any serious medical or mental illness/illness, including substance use disorders, may interfere with or limit adherence to study requirements/treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| LRR;DMR;DFS; | — |
Countries
China
Contacts
Public ContactChen Chuanben
Fujian Provincial Cancer Hospital
Outcome results
None listed