Head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
Conditions
Interventions
Experimental group1:Dose Escalation: Sapropterin dihydrochloride tablets
Experimental group2:Dose Expansion: Sapropterin dihydrochloride tablets
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma); 2. Aged 18 to 80 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 4. Head and neck radiotherapy alone or concurrent chemoradiotherapy, radiotherapy using intensity modulated radiotherapy; 5. Blood routine examination: HB >= 100g/L, PLT >= 75x10^9/L, WBC >= 3.0x10^9/L, ANC >= 1.5x10^9/L. Blood biochemistry: TBIL=60ml/min; 6. Have signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to sapropterin hydrochloride tablets or have more severe allergic constitution; 2. Those with poor compliance; 3. Pregnant or breastfeeding; 4. Have a history of head and neck radiotherapy; 5. Other patients (combined with any serious other diseases) considered by the investigator to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation dermatitis grading; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score;Incidence and duration of radiotherapy interruption due to severe radiation-induced skin reactions; | — |
Countries
China
Contacts
Public ContactPeng Xingchen
West China Hospital, Sichuan University
Outcome results
None listed