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Nasopharyngeal Carcinoma (NPC)Phase 2NCT07136519

Toripalimab, Induction Chemotherapy, Radiation Therapy With Omega-3 for Locally Advanced Nasopharyngeal Carcinoma

A Phase 2 study testing Toripalimab, Omega-3 and radiotherapy in people with Nasopharyngeal Carcinoma (NPC), run by Affiliated Hospital of Guangdong Medical University at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nasopharyngeal Carcinoma (NPC)
What is being tested?
Toripalimab, Omega-3 and radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesChina
Study dates
30 Jul 2025to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • ECOG score is 0-1 points.
  • Hemoglobin (HGB) ≥ 90g/L, white blood cell (WBC) ≥ 4.0 × 109/L, platelet (PLT) ≥ 100 × 109/L.
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  • Liver function: ALT and AST<2.5 times the upper limit of normal (ULN), total bilirubin<2.0 × UL, serum albumin ≥ 28g/L.
  • Renal function: Serum creatinine<1.5 × ULN or creatinine clearance rate (CrCl) calculated value ≥ 60mL/min (Cockcroft Gault formula).
  • Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group).
  • The international normalized ratio (INR) and activated partial thromboplastin time (APTT) are ≤ 1.5 × ULN (unless the subject is receiving anticoagulant treatment and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant treatment at the time of screening).

Who cannot join

  • 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.
  • HIV positive.
  • Have suffered from other malignant tumors (except for cured basal cell carcinoma or cervical carcinoma in situ).
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  • Patients who have been treated with immune checkpoint inhibitors (CTLA-4, PD-1, PD-L1, etc.).
  • Patients with immunodeficiency diseases and a history of organ transplantation.
  • Patients who have been treated with high-dose corticosteroids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.
  • Patients with significantly impaired heart, liver, lung, kidney, and bone marrow function.
  • Simultaneously using other investigational drugs or in other clinical trials.
  • Refusal or inability to sign the informed consent form for participation in the trial.
  • Individuals with personality or mental disorders, without civil capacity or with limited civil capacity.
  • hepatitis B B surface antigen (HBsAg) is positive and the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) is ≥ 1000 cps/ml.
  • Patients with positive HCV antibody test results are only eligible for this study if their HCV RNA polymerase chain reaction test results are negative.
  • Patients who have experienced any bleeding events with a severity rating of 3 or above in CTCAE5.0 within the first 4 weeks of screening and are deemed to have a high risk of bleeding by the researchers.
  • If there have been any arterial/venous thrombotic events within the 6 months prior to the start of screening, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
  • Patients with hypertension who cannot be reduced to the normal range through antihypertensive medication (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg); Based on the average of BP readings obtained from ≥ 2 measurements, there has been a history of hypertensive crisis or hypertensive encephalopathy.
  • Past or current inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea); History of previous or existing gastrointestinal perforation and/or fistula.
  • Known history of active pulmonary tuberculosis (TB). Subjects suspected of having active TB should undergo chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs.
  • Other serious, uncontrolled internal medical conditions and infections, or other contraindications to treatment, or any condition that researchers believe may pose a risk to receiving the study drug treatment, or interfere with the evaluation of the study drug, subject safety, or analysis of the study results.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Haiqing Luo, doctor contact

8613729196345

hqluo@126.com

China3 sites, 3 recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524001

    Haiqing Luo, M.D., +86 13729196345, hqluo@126.com

    haiqing Luo, M.D.

    Recruiting

  • Guangdong Nongken Central Hospital

    Zhanjiang, Guangdong, 524002

    ruiwen Huang, +86 13356519222, 718064629@qq.com

    ruiwen Huang

    Not yet recruiting

  • The Second Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524003

    hong Liu, +86 13828293012, 274803913@qq.com

    hong Liu

    Recruiting

Other trials in China

About this study

Official title: Toripalimab Plus Induction Chemotherapy Followed by Radiation Therapy Combined With Omega-3 for Locally Advanced Nasopharyngeal Carcinoma: A Phase II, Single Arm Clinical Trial

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.

Read the detailed description

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.

Being tested
Toripalimab, Omega-3, radiotherapy, Paclitaxel (albumin bound), Cisplatin
Keywords
Toripalimab, Omega-3
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToripalimabDrug

    Also called not have

    240mg Q3W

  • Omega-3Dietary supplement

    Also called not have

    During radiotherapy, take 6 capsules once a day

  • radiotherapyRadiation

    Also called not have

    radiotherapy

  • Paclitaxel (albumin bound)Drug

    Also called not have

    260mg/m2 d1,Q3W

  • CisplatinDrug

    Also called not have

    80mg/m2 d2, Q3W

Study groups in NCT07136519
Study groupRoleWhat they receive
Toripalimab Plus Omega-3ExperimentalToripalimab Plus Induction Chemotherapy Followed by Radiation Therapy Combined with Omega-3
Receives: Drug: Toripalimab; Dietary Supplement: Omega-3; Radiation: radiotherapy; Drug: Paclitaxel (albumin bound); Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the end of treatment at 2 years

Secondary outcomes (5)

  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.

    Measured: From enrollment to the end of treatment at 2 years

  2. 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.

    Measured: From enrollment to the end of treatment at 2 years

  3. Adverse reactions

    According to the National Cancer Institute's Common Terminology Criteria for Adverse Events v5.0 grading.

    Measured: From enrollment to the end of treatment at 2 years

  4. 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.

    Measured: From enrollment to the end of treatment at 2 years

  5. 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).

    Measured: From enrollment to the end of treatment at 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start30 Jul 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07136519
Sponsor's protocol ID
PJ2025-005
Status last verified
Oct 2026
First submitted
1 Aug 2025
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab, Omega-3 and radiotherapy in people with Nasopharyngeal Carcinoma (NPC), run by Affiliated Hospital of Guangdong Medical University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haiqing Luo, doctor (8613729196345, hqluo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year progression free survival period (time frame: From enrollment to the end of treatment at 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07136519.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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