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.
Written informed consent can be provided, and understanding and compliance with research requirements and evaluation schedules are required.
On the date of signing the informed consent form, the age range is between 18 and 65 years old (or the legal age specified by local laws).
Pathological diagnosis is non keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated, i.e. WHO classification II or III).
Clinical staging is anyTN2-3M0 or T4N1M0 (AJCC8th/UICC staging).
Nasopharyngeal cancer patients with recurrence and distant metastasis.
Pathology shows keratinized squamous cell carcinoma (WHO classification type I).
Patients who have undergone radiotherapy or systemic chemotherapy before.
Pregnant or lactating women who are in the reproductive period and have not taken effective contraceptive measures.
Single group
Toripalimab
Drug240mg Q3W
Omega-3
Dietary supplementDuring radiotherapy, take 6 capsules once a day
radiotherapy
Radiationradiotherapy
Paclitaxel (albumin bound)
Drug260mg/m2 d1,Q3W
Cisplatin
Drug80mg/m2 d2, Q3W
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.
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.
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.
Adverse reactions
According to the National Cancer Institute's Common Terminology Criteria for Adverse Events v5.0 grading.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
