Head and Neck Malignancies
Conditions
Interventions
experiment group:Pembrolizumab combined with albumin taxol plus cisplatin
control group:albumin taxol and cisplatin
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, male or female; 2. Pathologically diagnosed advanced head and neck malignant tumors with measurable lesions (spiral CT scan >= 10 mm, meeting RECIST 1.1 criteria); 3. Advanced, recurrent or metastatic head and neck malignant tumors that cannot be operated or radiotherapy; 4. According to CTCAE 4.0 and the patient's chief complaint, the researchers judged patients with intolerable pd-1 combined with chemotherapy; 5. ECOG PS: 0-1; 6. Baseline blood routine and biochemical indicators meet the following criteria: - hemoglobin >= 80g/L, - absolute count of neutrophils (ANC) >= 1.5×10^9/L, - platelet >= 90×10^9/L, - ALT and AST= 30g/L; 7. Expected survival >= 3 months; 8. Women of child-bearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and have negative results, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug. For men, surgical sterilization or consent to appropriate contraceptive methods during the trial and 8 weeks after the last administration of the trial drug; 9. Subjects volunteered to participate in this study and signed informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Confirmed allergy to albumin taxol and/or its excipients; 2. Hypertensive patients (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) with grade I or above coronary heart disease, grade I arrhythmia (including prolonged QTc interval > 450 ms in men and > 470 ms in women) and grade I cardiac dysfunction; Patients with positive urinary protein; 3. Multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 4. Patients who have received albumin paclitaxel and/or paebolizumab; 5. Active autoimmune diseases requiring systemic treatment in the past 2 years; 6. Patients with central nervous system metastasis; 7. Pregnant or lactating women; 8. Patients with other malignant tumors within 5 years; 9. Patients with a history of psychotropic substance abuse who are unable to quit or have mental disorders; 10. Patients who participated in clinical trials of other drugs within 4 weeks; 11. According to the judgment of the researcher, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 12. Ineligible subjects considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EGFR expression level in tumor tissues;Mutation of k-ras gene;P16 gene expression;HPV gene expression;TGF- 1 in plasma;OS;PFS;ORR;DCR;SAE; | — |
Countries
China
Contacts
Public ContactLiu Ping
The Second Xiangya Hospital of Central South University
Outcome results
None listed