Nasopharyngeal Cancinoma (NPC)
Conditions
Brief summary
This study aimed to investigate the efficacy of a platinum-free neoadjuvant regimen (gemcitabine, camrelizumab, endostar, and low-dose radiotherapy) followed by a risk-adapted therapeutic strategy in patients with locally advanced nasopharyngeal carcinoma. Specifically, the risk-adapted approach was defined as follows: patients achieving a complete response after neoadjuvant therapy received radiotherapy alone; those with a partial response received radiotherapy plus concurrent endostar; and those with stable disease or progressive disease received radiotherapy plus concurrent cisplatin.
Interventions
Low-dose radiotherapy
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 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age at diagnosis between 18 and 70 years. 2. Histopathologically confirmed newly diagnosed nasopharyngeal carcinoma, classified as non-keratinizing carcinoma or keratinizing squamous cell carcinoma according to the World Health Organization (WHO) classification. 3. Diagnosed with stage II/III nasopharyngeal carcinoma (excluding T3N0) based on the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system, 9th edition. All subjects must undergo the following examinations prior to the initiation of first-line treatment to confirm clinical staging: complete medical history, physical examination, routine blood tests and biochemical assays, plasma Epstein-Barr virus (EBV) DNA titer and serological tests, nasopharyngoscopy, head and neck magnetic resonance imaging (MRI), and ¹⁸F-fluorodeoxyglucose positron emission tomography (¹⁸F-FDG PET). 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 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 |
|---|---|
| Recurrence-free survival | Time from enrollment to the first occurrence of disease recurrence (including distant metastasis or locoregional recurrence) or death from any cause, whichever occurs first, assessed up to 60 months. |
Countries
China
Contacts
CONTACTCaineng Cao, MD
PRINCIPAL_INVESTIGATORXiaozhong Chen, MD
Zhejiang Cancer Hospital
Outcome results
None listed