head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Fluzoparib combined with Cisplatin and Intensity Modulated Radiotherapy Treatments
Sponsors
Lianyungang First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years old, gender unlimited, expected survival of more than 12 weeks; (2) Patients with oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer and inoperable oral cancer confirmed by histology or cytology; (3) The eighth edition of AJCC is divided into III-IVB phases; (4) Have measurable lesions (RECIST 1.1); (5) ECOG score was 0-2, and could tolerate radiotherapy; (6) White blood cells =4.0*109/L, neutrophil absolute number =1.5*109/L, platelets =100*109/L, hemoglobin =100g/L; Serum albumin =30g/L; Bilirubin = 1.5×ULN; ALT and AST=2.5 x ULN; Normal renal function; (7) can accept =2 cycles of induction chemotherapy; (8) The patient signed the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1) Pregnant or nursing women; (2) previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ; (3) Inability to swallow pills normally or abnormal gastrointestinal function, which may affect drug absorption according to the researchers; (4) There are clinical symptoms or diseases of the heart that are not well controlled, such as: heart failure of A.NHA2 or above; b. Unstable angina pectoris; c. Myocardial infarction within 1 year; d. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; e.QTc> 470ms; (5) Patients with abnormal coagulation function (INR > 1.5 or PT > ULN+4 seconds), bleeding tendency or receiving thrombolytic or anticoagulant therapy are allowed to receive low-dose low-molecular weight heparin or oral aspirin prophylactic anticoagulant therapy during the trial; (6) Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive, HBV DNA=500 IU/ml; Hepatitis C reference: HCV antibody positive, HCV virus copy number > Upper limit of normal value); (7) a known major active infection, or a major hematological, renal, metabolic, gastrointestinal, endocrine, or metabolic disorder determined by the investigator, or other serious uncontrolled concomitant disease; (8) In the judgment of the investigator, the subjects have other factors that may lead to the forced termination of the study, such as other serious diseases (including mental illness) requiring combined treatment, serious abnormalities in laboratory tests, and family or social factors that may affect the safety of the subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal Tolerable Dose;dose limiting toxicity DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safty;ORR; | — |
Countries
China
Contacts
Public ContactYuwei Fan
Lianyungang First Peoples Hospital
Outcome results
None listed