The aim of this study is to evaluate the efficacy, adverse reactions, nutritional status analysis, and quality of life analysis of Toripalimab Plus Induction Chemotherapy Followed by Radiation Therapy Combined with Omega-3 in the treatment of locally advanced nasopharyngeal carcinoma.
After being informed about the study and potential risks, all patients giving written informedconsent will undergo a 1-week screening period to determine eligibility for study entry. In week 0, eligible patients will be enrolled in a clinical study on the combination of Toripalimab, induction chemotherapy, sequential radiotherapy, and OMEGA-3 for the treatment of locally advanced nasopharyngeal carcinoma. Induction chemotherapy stage: Toripalimab 240mg d1, paclitaxel (albumin bound) 260mg/m2 d1, cisplatin 80mg/m2 d2 Q3W X 3 cycles. Radiotherapy stage: IMRT+Toripalimab 240mg Q3W X 3 cycles+Omega-3 (6 pills qd during radiotherapy). IMRT:GTVnx 69.96Gy,GTVnd 69.96Gy,CTV1 60Gy,CTV2 54Gy。 Maintenance treatment: Toripalimab 240mg Q3W X 6 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
240mg Q3W
During radiotherapy, take 6 capsules once a day
radiotherapy
2-year progression free survival period
It refers to the probability of disease progression or death from any cause objectively recorded from a random date within two years, evaluated according to RECIST v1.1.
Time frame: From enrollment to the end of treatment at 2 years
objective response rate
It refers to the proportion of patients who achieve complete or partial remission, evaluated by an independent review committee based on RECIST v1.1 for all randomized patients with measurable disease at baseline.
Time frame: From enrollment to the end of treatment at 2 years
Overall survival
It refers to the period from a random date to the date of death for any reason, evaluated according to RECIST v1.1.
Time frame: From enrollment to the end of treatment at 2 years
Adverse reactions
According to the National Cancer Institute's Common Terminology Criteria for Adverse Events v5.0 grading.
Time frame: From enrollment to the end of treatment at 2 years
Quality of life score
Evaluate through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer-35 module and Core 30.For EORTC QLQ - H\&N35: Title: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer - 35 Range: Items 1-4, subscales vary. Meaning: Higher symptom scores = worse outcome; higher functional scores (if any) = better function. For EORTC QLQ - C30: Title: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Range: 0-100 for scales. Meaning: Higher functional scores = better outcome; higher symptom scores = worse outcome. Align with standardized scoring.
Time frame: From enrollment to the end of treatment at 2 years
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260mg/m2 d1,Q3W
80mg/m2 d2, Q3W
Nutritional status analysis
Assess nutritional status based on body mass index.Unabbreviated scale title: Body Mass Index (BMI) Minimum and maximum values: Theoretically, BMI can range from near 0 to over 100, but in practical clinical and research contexts for assessing human nutritional status, the typical relevant range is approximately 10 to 60. Higher scores meaning: A BMI within the normal range (18.5 - 24.9 for adults) indicates a better nutritional outcome (appropriate weight for height, supporting good health). Scores lower than 18.5 (underweight) mean a worse outcome (increased risk of nutritional deficiencies). Scores higher than 24.9 (overweight or obese, with obesity classes having higher values) also mean a worse outcome (increased risk of various health problems related to excess weight).
Time frame: From enrollment to the end of treatment at 2 years