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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab Plus Omega-3 | Experimental | Toripalimab Plus Induction Chemotherapy Followed by Radiation Therapy Combined with Omega-3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | 240mg Q3W |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 2 years |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiqing Luo, doctor | Contact | 8613729196345 | hqluo@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Haiqing Luo, doctor | Guangdong Medical University Affiliated Hospital | Principal Investigator |
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Individual participant data (IPD), including de - identified demographic information, clinical outcomes, and treatment details, will be shared with qualified researchers upon request. Access will be provided via a secure data repository after review and approval of a data access request form to ensure compliance with ethical and legal standards.
IPD will become available 6 months after the primary study results are published in a peer - reviewed journal. The data will remain accessible for a period of 5 years to facilitate secondary analyses and research replication.
To access IPD, researchers must: (1) Be affiliated with a recognized academic or research institution; (2) Submit a request detailing the research question, methodology, and how the data will contribute to advancing knowledge in the field; (3) Provide evidence of ethical approval from their local IRB for the proposed secondary analysis; (4) Agree to use de - identified data only and not attempt to re - identify participants. Access is granted at the discretion of the study's data governance board after a full review of the request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2025 |
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| Omega-3 | Dietary Supplement | During radiotherapy, take 6 capsules once a day |
|
|
| radiotherapy | Radiation | radiotherapy |
|
|
| Paclitaxel (albumin bound) | Drug | 260mg/m2 d1,Q3W |
|
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| Cisplatin | Drug | 80mg/m2 d2, Q3W |
|
|
It refers to the period from a random date to the date of death for any reason, evaluated according to RECIST v1.1. |
| 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. | 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. | From enrollment to the end of treatment at 2 years |
| 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). | From enrollment to the end of treatment at 2 years |
| Aug 1, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2025 | Aug 1, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D004281 | Docosahexaenoic Acids |
| D011878 | Radiotherapy |
| D013660 | Taxes |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D013812 | Therapeutics |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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