Squamous cell carcinoma of head and neck
Conditions
Sponsors
Inner Mongolia Autonomous Region People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Ages 18-75 years, including 18 and 75 years; (2) ECOG PS score 0-2; (3) through pathological histology and cytology diagnose III - IV b period (according to step 2020 head and neck cancer guidelines) head and neck squamous cell carcinomas (including oral and oropharyngeal cancer, stomach cancer, laryngeal cancer, but except for nasopharyngeal carcinoma); (4) Histopathological immunohistochemical test indicated positive EGFR expression; (5) Patients who are not suitable for surgery (defined as patients whose physical conditions do not permit or refuse surgery for various reasons); (6) According to the evaluation criteria of RECIST version 1.1, there is at least one measurable lesion; (7) Suitable for radiotherapy and chemotherapy for the purpose of radical cure; (8) Expected survival time >= 3 months; (9) Hematological indicators were basically normal: white blood cell count >= 4 x 10^9/L; The absolute count of neutrophils >= 1.5 x 10^9/L; Platelet >= 100 x 10^9/L; Hemoglobin >= 90 g/L; (10) basically normal renal function: serum creatinine = 60mL/min; (11) Basically normal liver function: serum total bilirubin <= 1.5 x ULN (in case of liver metastasis, serum total bilirubin <= 3.0 x ULN); AST and ALT <= 2.5 x ULN (<= 5.0 x ULN, if liver metastasis is present); (12) Female patients must have a negative urine pregnancy test prior to study initiation (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients); (13) Sign written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients who have received radiotherapy, chemotherapy, monoclonal antibody, oral EGFR-TKI treatment, anti-angiogenic drugs and immunosuppressive agents within half a year; (2) Participate in other interventional clinical trials within 30 days before screening; (3) Patients with distant metastasis; (4) A history of other malignant tumors (except cured cervical carcinoma in situ or basal cell carcinoma of the skin and other malignant tumors that have been cured for more than 5 years); (5) The presence of poorly controlled concurrent diseases (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); (6) Known HIV infection or active viral hepatitis; (7) is receiving chronic steroid hormone therapy for more than 6 months (e.g. prednisone dose > 10 mg/ day or equivalent); (8) Those who are allergic to the drugs used in the program or their ingredients; (9) >= level 2 peripheral neurological disease or hearing loss according to the common adverse event term (NCI CTCAE V5.0); (10) Pregnancy (confirmed by blood or urine HCG test) or lactating women, or subjects of childbearing age who are unwilling or unable to use effective contraceptive methods (for both male and female subjects) until at least 6 months after the last trial treatment; (11) The researcher considers it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year progression-free survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate (ORR);Total tumor response rate (CRR);Disease Control Rate;2 year total survival (OS) rate;Local control rate for 2 years ;Median totale survival (OS);Medina progression-free survival (PFS);living quality; | — |
Countries
China
Contacts
Public ContactJingaowa?Jiaming
Inner Mongolia Autonomous Region People's Hospital
Outcome results
None listed