Nasopharyngeal Carcinoma
Conditions
Brief summary
Neoadjuvant chemotherapy plus toripalimab in patients with locoregionally advanced nasopharyngeal carcinoma
Interventions
DRUGToripalimab
Toripalimab (240 mg Q3W for 3 cycles) combine with chemotherapy
3 cycles of intravenous induction gemcitabine (1 g/m2 on days 1 and 8 of each 3-week cycle) once every 3 weeks
DRUGCisplatin
3 cycles of intravenous induction cisplatin (80 mg/m2 on day 1) once every 3 weeks.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18 to 65; 2. Pathological type: non-keratinizing carcinoma (World Health Organization criteria); 3. Diagnosed with LANPC according to the 8th edition clinical staging system of the American Joint Committee on Cancer \[AJCC\]/Union for International Cancer Control \[UICC\]; 4. ECOG performance score: 0 to 1; 5. Normal bone marrow function: white blood cell count \> 4×109/L, hemoglobin \> 90g/L, platelet count \> 100×109/L; 6. Normal values of thyroid function, amylase and lipase examination, pituitary function, inflammation and infection indicators, myocardial enzymes, and ECG results. For patients older than 50 years with a smoking history, normal lung function are required. Patients with abnormal ECG and/or a history of vascular disease (but not meeting the
Exclusion criteria
listed in the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | 9 weeks | CR assessed by investigator, according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI). Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival(OS) | 3 years | defined as the time from the date of enrollment to death from any cause or censored at the date of last follow-up. |
| Locoregional failure-free survival(LRRFS) | 3 years | defined as the time from the date of enrollment to local or regional relapse, or death from any cause. |
| Distant metastasis-free survival(DMFS) | 3 years | defined as the time from the date of enrollment to distant metastasis, or death from any cause. |
| Number of participants with adverse events | up to 3 years | Numbers of patients of treatment-related adverse events were assessed by CTCAE v5.0. |
| Quality of life (QoL): questionnaire | Week 1,9,16,28 | QoL is evaluated with the use of the head-and-neck-specific module (H\&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30), which is established by European Organization for Research and Treatment of Cancer (EORTC). Scores for the module range of H\&N35 QLQ-C30 from 0 to 100, with higher scores indicating better functioning or well-being or higher symptom burden (scales measuring symptom burden were reverse-scored to facilitate presentation) |
Countries
China
Outcome results
None listed