Head and neck squamous cell carcinoma
Conditions
Interventions
experimental group:Sintilimab+ chemotherapy + radiotherapy
control group:Placebo + SOC radiotherapy and chemotherapy
Sponsors
The Second Affiliated Hospital of Guangxi University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years; 2. Patients with stage III and IV head and neck squamous cell carcinoma confirmed by pathology or histology; 3. Patients with at least one measurable lesion (spiral CT scan >= 10 mm); 4. Patients who have not received radical radiotherapy or concurrent chemoradiotherapy, immunotherapy or targeted therapy; 5. ECOG score: 0-1; 6. Patients whose expected survival time is more than or equal to 3 months; 7. (1) Routine blood examination standards must meet: HB >= 90 g/L, ANC >= 1.5x10^9/L, PLT >= 80x10^9/L; (2) The biochemical examination should meet the following standards: TBIL 45 ml/min (Cockcroft- Gault formula); 8. The patients who volunteered to join the study signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with abnormal functions of heart, brain, lung and other important organs; 2. History of other malignant tumors before enrollment; 3. Clinically severe active > grade 2 (NCI-CTC version 5.0); 4. Pregnant or lactating female patients; 5. Patients had received other study medications within 4 weeks of participating in the study; 6. Other conditions considered by the researcher not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Disease control rate;Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Living Quality; | — |
Countries
China
Contacts
Public ContactLan Liu
The Second Affiliated Hospital of Guangxi University of Science and Technology
Outcome results
None listed