Locally advanced head and neck squamous cell carcinoma
Conditions
Interventions
Experimental Arm:DHA+Chemoradiotherapy
Sponsors
Bethune International Peace Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Over 18 years old (including 18 years old) and under 75 years old (including 75 years old). 2. Patients with unresectable stage III NSCLC confirmed by histology (according to AJCC 8th Edition lung cancer staging criteria). Unresectable stage III NSCLC includes partial IIIA, IIIB, and all IIIc stages. It usually includes N2 patients with short diameter of mediastinal lymph nodes >= 3 cm at single station or multiple stations, N2 patients with multi station lymph node fusion (short diameter of lymph nodes >= 2 cm on CT), T4 patients with invasion of esophagus, heart, aorta, and pulmonary vein, and all N3 patients. 3. Patients with unresectable stage III NSCLC who have not received any systemic or local treatment. 4. Patients with unresectable stage III NSCLC whose tumor tissue samples or blood samples were confirmed as EGFR sensitive mutations by central laboratory tests (including exon 19 deletion or L858R, either alone or coexisting with other EGFR mutations). If the tumor tissue is accessible, it is recommended to send the tumor tissue for examination; if the tumor tissue is not accessible or the patient cannot accept the tissue biopsy, the blood sample is sent for examination. 5. Patients with ECoG score of 0 or 1 and no deterioration in the previous 2 weeks had a minimum expected survival of 12 weeks. 6. For patients with at least one tumor lesion that can be accurately measured at baseline, the longest diameter at baseline is greater than or equal to 10 mm (if it is a lymph node, the shortest diameter is greater than or equal to 15 mm). The selected measurement method is suitable for accurate repeated measurement, which can be computed tomography (CT) or magnetic resonance (MRI). If there is only one measurable lesion, it can be accepted as the target lesion, and the baseline evaluation of tumor lesions should be performed at least 14 days after the diagnostic biopsy. 7. Women of childbearing age should take appropriate contraceptive measures from screening to 3 months after stopping the study treatment, and should not breastfeed. Before administration, the pregnancy test was negative, or one of the following criteria was met to prove that there was no risk of pregnancy: (1) Postmenopausal was defined as amenorrhea for at least 12 months after the age of 50 years and the cessation of all exogenous hormone replacement therapy. (2) Women younger than 50 years old with amenorrhea for 12 months or more after cessation of all exogenous hormone therapy, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the range of laboratory postmenopausal reference value, can also be considered as postmenopausal. (3) Previous irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral salpingectomy, except bilateral tubal ligation. 8. Male patients should use barrier contraception (i.e. condom) from screening to 3 months after discontinuation of study treatment. 9. Patients who voluntarily participated and signed informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. Patients with postoperative recurrence. 2. Non newly diagnosed patients with previous treatment (including but not limited to tyrosine kinase inhibitors, neoadjuvant therapy, surgical resection and / or use of any experimental drugs). 3. Patients who have received any of the following treatments: (1) Any EGFR tyrosine kinase inhibitor has been used in the past; (2) Any previous chemotherapy for head and neck cancer; (3) Any previous radiotherapy for head and neck cancer; (4) Within 4 weeks before the first administration of the study drug, the patient had undergone major surgery; 4. Patients with other malignant tumors who need standard treatment or major surgery within 2 years after the first administration of the study treatment. 5. At the beginning of the study, there were unrelieved residual toxicity greater than CTCAE grade 1, except for grade 2 neurotoxicity caused by alopecia and previous chemotherapy. 6. Patients who lost more than 10% of their weight in the previous month. 7. According to the judgment of the researcher, patients with any serious or poorly controlled systemic diseases, such as poorly controlled hypertension, uncontrolled angina pectoris, arrhythmia, congestive heart failure, decompensated liver cirrhosis, active bleeding prone constitution or active infection. There is no need to screen for chronic diseases. 8. Patients with refractory nausea, vomiting or chronic gastrointestinal diseases who cannot swallow the study drug or have undergone extensive intestinal resection may affect the full absorption of DHA. 9. Meet any of the following cardiac examination results: (1) The mean corrected QT interval (QTC) > 470 msec was obtained by three ECG examinations at rest. The QTCF was corrected by fridericia formula; (2) Resting ECG indicated various clinically significant rhythms, conduction or ECG morphological abnormalities (such as complete left bundle branch block, 3-degree atrioventricular block, 2-degree atrioventricular block and PR interval > 250 msec); (3) There are any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death of immediate relatives under 40 years old or any combination of drugs that prolong QT interval; (4) Left ventricular ejection fraction (LVEF) 2.5-fold upper normal limit (ULN); Aspartate aminotransferase > 2.5 * ULN; Total bilirubin > 1.5 * ULN; or Gilbert syndrome (unconjugated hyperbilirubinemia); Creatinine > 1.5 * ULN and creatinine clearance 1.5 * ULN, the creatinine clearance should be confirmed. 11. Women with positive blood or urine pregnancy test results during lactation or within 3 days before the first administration of study treatment. 12. Patients with a history of hypersensitivity to any active or inactive component of DHA or to drugs similar to or similar to DHA. 13. Patients allergic to EGFR mAb or any other component of the preparation, cisplatin or other platinum containing compounds. 14. Patients with contraindications of cisplatin and EGFR mAb. 15. Patients with an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;DoR;Safety; | — |
Countries
China
Contacts
Public ContactQi Song
Bethune International Peace Hospital
Outcome results
None listed