Head and neck squamous cell carcinaoma
Conditions
Interventions
Case series:Albumin paclitaxel plus platinum and toripalimab
Sponsors
Shenzhen Hospital of cancer hospital of Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Squamous cell carcinoma confirmed by pathology (histology or cytology); 2. No prior systemic therapy administered in the recurrent or metastatic settingor systemic therapy completed > 6 months prior if given as part of multimodal treatment for locally advanced disease; 3. Aged 18 to 70 years old; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 5. At least one measurable lesion according to RECIST1.1; 6. Adequate organ function(No blood transfusion, Hematopoietic stimulating factor or drugs are allowed 14 days within the firstmedication)neutrophils >=1.5x10^9/L, hemoglobin>=90g/Lthrombocyte >=100x10^9/L, AST and ALT =3 months; 8. Willingness to receive long-term follow up;Can provide tissue for PD-L1 biomarke, and NGS detection, and willingness to offer blood sample prior to and post treatment; 9. Ability to understand and willingness to sign a written informed consent document prior to the enrollment of the trial.
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically verified pathological subtype as non-squamous cell carcinoma; 2. Allergic to albumin paclitaxel; platinum or toripalimab; 3. Previous administration of anti-PD-1/PD-L1 treatment; 4. Symptomatic central nervous system metastases; 5. Diagnosed and/or treated additional malignancy prior to randomization with the exception of curatively treated carcinoma of the skin, or curatively resected in situ cervical or breast cancers; 6. History of active autoimmune disease; 7. Innate or acquired immune deficiency; 8. History of allogeneic organ transplantation with the exception of corneal transplantation; 9. Active infection requiring systemic therapy or a fever of unknown origin with body temppreture >38.5°before the first medication; 10. Known active Hepatitis B or C or history of human immunodeficiency virus (HIV); 11. Psychiatric medication abuse or psychiatric illness that would limit the compliance with the study requirement; 12. Uncontrolled concomitant diseases that would limit the medication according to the study requirements; 13. Women in pregnancy and lactation; 14. Known poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactDu Chunxia
Shenzhen Hospital of cancer hospital of Chinese Academy of Medical Sciences
Outcome results
None listed