recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC)
Conditions
Interventions
experimental group: Utidelone plus Tirelizumab
Sponsors
Zhongnan Hospital Affiliated to Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Signed informed consent • Patient must be at least 18 years of age and not older than 75 years of age. • Histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma; •ECOG Physical Fitness Score (PS) 0-1; • At least one measurable lesion (assessed according to solid tumor response Criteria (RECIST1.1)) • Recurrent/metastatic head and neck squamous cell carcinoma stage has failed to receive first-line standard regimens; • All toxicities that have occurred in patients associated with previous antitumor therapy must return to = grade 1 (CTCAE v5.0). However, patients with any level of hair loss were allowed to enter the study. • The blood routine examination within 1 week before enrollment was basically normal - white blood cell count (WBC) = 2.5 × 109/L; - Neutrophil count (ANC) = 1.5 × 109/L; - Platelet count (PLT) = 100 × 109/L; - Hemoglobin = 9.0 g/dL. Patients may receive blood transfusions or treatment with erythropoietin to meet this standard; • Liver and kidney function tests were basically normal within 1 week before enrollment -- total bilirubin (TBIL) = 1.5× upper limit of normal (ULN); - Alanine aminotransferase (SGPT/ALT) = 2.5×ULN (patients with liver metastasis =5×ULN); - Aspartate aminotransferase (SGOT/AST) = 2.5×ULN (=5×ULN in patients with liver metastasis); Creatinine clearance (Ccr) =60 ml/min; ? Fertile patients must consent to use an effective contraceptive method during the study period and within 90 days of the last study medication. Female patients must have a negative blood or urine pregnancy test prior to enrollment. ? Patients with a life expectancy of at least 12 weeks must be able to participate in and comply with treatment and follow-up.
Exclusion criteria
Exclusion criteria: ? other malignancies (including primary brain or pia meningeal tumors) within the past 5 years, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; ? Antitumor therapy, including chemotherapy, radical radiotherapy, hormone therapy, biotherapy, or antitumor Chinese medicine therapy, was administered within 4 weeks prior to treatment initiation. ? had major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the study drug, or required elective surgery during the trial period. ? In patients with = grade 3 neurological adverse reactions after previous use of anti-microtubule drugs. ? symptomatic central nervous system metastases ? Pregnant or lactating women ? known or suspected allergy to any investigational drug or excipient ? patients with serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infections, active gastrointestinal ulcers, and a history of uncontrolled mental illness. ? Any other condition in which participants are prohibited from using corticosteroids under which the investigator deems it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;Time to remission;Duration of remission;overall survival; | — |
Countries
China
Contacts
Public ContactZhong Yahua
Zhongnan Hospital Affiliated to Wuhan University
Outcome results
None listed