Squamous cell carcinoma of head and neck
Conditions
Interventions
control group:Pain medication plus concurrent chemoradiotherapy
Experimental group:Nimotuzumab + pain medication + concurrent chemoradiotherapy
Sponsors
Department of Head and Neck Surgery, Baotou Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The age is 18-90 years, including 18 years old, excluding 90 years old; (2) ECoG PS score 0-2; (3) Stage III - IV B (according to the guidance for diagnosis and treatment of head and neck tumors in CSCO 2020) with histopathology or cytology (including oral, oropharyngeal, hypopharyngeal and laryngeal cancers, but excluding NPC); (4) The expression of EGFR was positive by immunohistochemistry (5) Patients who are not suitable for surgery (defined as patients whose physical conditions do not allow or refuse to operate for various reasons); (6) According to the evaluation standard of RECIST 1.1, there is at least one measurable lesion, CT scan >= 10 mm clinical routine examination instrument >= 10 mm (the tumor focus that cannot be measured accurately by diameter measuring instrument shall be recorded as non measurable), chest X-ray >= 20mm; malignant lymph nodes: pathological enlargement and measurability; CT scan short diameter of single lymph node is >= 15mm (CT scanning layer thickness is not more than 5mm); (7) It is suitable for comprehensive treatment for radical or palliative purposes. (8) The score of pain scale before treatment was NRs >= 1; Patients who have not used opioid drugs are to use opioid drugs for analgesia; for patients with weak opioids, the control effect is not good at present, so it is necessary to control the strong opioids; when patients with moderate and severe cancer pain are using strong opioid analgesics, the pain cannot be effectively controlled; the pain that the patient is difficult to control needs to be intervened as soon as possible. The existing ones The therapeutic effect is not good; (9) The expected survival time was >= 3 months; (10) The hematological indexes were normal: leukocyte count >= 4 x 10^9/l; neutrophil absolute count >= 1.5 x 10^9/l; platelet >= 100 x 10^9/l; hemoglobin >= 90 g / L; (11) Renal function is basically normal: serum creatinine = 60ml/min (12) The liver function is basically normal: the total bilirubin in serum is <= 1.5 x ULN (if there is liver metastasis, the total bilirubin in serum should be <= 3.0 x ULN); the AST and ALT are less than 2.5 x ulin (< 5.0 x ulin, if there is liver metastasis). (13) Women must have a negative urine pregnancy test before the study begins (not for patients with bilateral ovariectomy and / or hysterectomy or postmenopausal). (14) Sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients who received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI, anti angiogenic drugs and immunosuppressors were received within half a year; (2) Other intervention clinical trials were conducted within 30 days before screening; (3) Patients with distant metastasis; (4) Other malignancies (except for the cured cervical in situ or skin basal cell carcinoma and other malignant tumors that have been cured for more than 5 years); (5) There are some diseases (such as heart failure, diabetes, hypertension, thyroid disease, mental disease, etc.) which are not well controlled; (6) It is known that the patients with HIV or active viral hepatitis are seriously infected with HIV (> Level 2 infection standard); (7) Chronic steroid therapy is being given for more than 6 months (e.g. prednisone dose > 10 mg/ day or equivalent); (8) Allergic to the drug or its components used in the scheme; (9) According to the standard of common adverse event terminology (NCI CTCAE V5.0), the patients were >= 2 peripheral nerve disease or hearing loss; (10) Pregnancy (confirmed by blood or urine HCG test) or lactation women, or subjects of childbearing age are unwilling or unable to take effective contraceptive measures (both for men and women) until at least 6 months after the last trial treatment; (11) The researchers think it is not suitable for the participants; (12) Those who are unwilling to participate in the study or cannot sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| CRR;ORR;DCR;LRC;PFS;OS;MPFS;living quality; | — |
Countries
China
Contacts
Public ContactHan Bo
BaoTou Cancer Hospital
Outcome results
None listed