Recurrent or metastatic squamous cell carcinoma of head and neck
Conditions
Interventions
Experimental group:Paclitaxel and nedaplatin regimen combined with camrelizumab therapy
Sponsors
Guizhou Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Head and neck squamous cell carcinoma confirmed by histology or cytology; 3. Patients who have previously received postoperative radiotherapy or radical radiotherapy and chemotherapy for more than 6 months, and have recurrence after surgery or radiotherapy and chemotherapy, or stage IVc at the time of initial diagnosis (staging according to the Eighth Edition of the International Union for Cancer Control (UICC)); 4. At least one measurable lesion according to RECIST1.1 solid tumor evaluation criteria; 5. Recurrent/metastatic lesions without appropriate local treatment; 6. Normal bone marrow function: neutrophils>1.5x10^9/L, hemoglobin>90g/L and platelet count>100x10^9/L; 7. Normal liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) 60 ml/min; 9. ECOG score 0-1, G8 score >= 11; 10. With a signed and dated written informed consent in compliance with ICH-GCP and local legal requirements.
Exclusion criteria
Exclusion criteria: 1. HBsAg positive and HBV DNA >1×10^3 copies/ml. 2. HCV antibody positive. 3. Active, known or suspected autoimmune disease. Subjects with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, and skin disorders that do not require systemic treatment (eg, vitiligo, psoriasis, or alopecia) may be enrolled. 4. A history of interstitial lung disease. 5. Received systemic hormones or other immunosuppressive therapy with an equivalent dose of >10 mg prednisone/day within 28 days before signing the informed consent. Subjects with systemic corticosteroid doses <=10 mg prednisone/day or inhaled/topical corticosteroids were eligible. 6. Have been vaccinated or will be vaccinated with live vaccines within 30 days before signing the informed consent form. 7. Pregnant or lactating subjects (pregnancy test should be considered for women who are sexually active and fertile). 8. Other malignant tumors within 5 years, except carcinoma in situ, fully treated non-melanoma skin cancer and papillary thyroid carcinoma. 9. The subject is known to have a history of hypersensitivity to macromolecular protein preparations, or any of the components of camrelizumab. 10. Human immunodeficiency virus (HIV) infection. 11. Other conditions judged by the investigator that may affect subject safety or trial compliance, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic treatment, mental illness or family and social factors, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (objective response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS (Progression free survival);OS (Overall survival);DCR (Disease control rate);Security;Treatment completion rate; | — |
Countries
China
Contacts
Public ContactJin Feng
Guizhou Cancer Hospital
Outcome results
None listed