Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 to 65

Toripalimab with induction chemo, radiation, and Omega-3 for locally advanced nasopharyngeal cancer

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

Run by Affiliated Hospital of Guangdong Medical University · NCT07136519 · Data updated 2026-11-12

This study tests whether adding toripalimab and Omega-3 to induction chemotherapy and radiation helps patients with locally advanced nasopharyngeal carcinoma.

More Nasopharyngeal Carcinoma (NPC) trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment30 (estimated)
SponsorAffiliated Hospital of Guangdong Medical University
Academic / other
Drugs / interventionschemotherapy, Toripalimab, Radiation
Locations3 sites (Zhanjiang, Guangdong and 2 other locations)
StatusRecruiting
StartedJuly 30, 2025
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedOctober 29, 2026
Trial IDNCT07136519 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–65 with non-keratinizing nasopharyngeal carcinoma, stage AJCC 8th edition TN2-3M0 or T4N1M0, ECOG 0–1, adequate organ function, and ability to consent.

Probably not a fit

Patients with poor performance status, significant organ dysfunction, or disease beyond the specified stage may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial evaluates the combination of toripalimab, induction chemotherapy, sequential radiotherapy, and Omega-3 in adults with locally advanced nasopharyngeal carcinoma. Eligible participants undergo a 1-week screening, followed by induction chemotherapy with toripalimab, paclitaxel, and cisplatin, then radiotherapy with continued toripalimab and Omega-3, and finally maintenance toripalimab. Outcomes include efficacy, safety, nutritional status, and quality of life. The study uses standard IMRT dosing and includes explicit eligibility criteria related to performance status, organ function, and disease stage.

Why it matters

Potential benefit: If successful, this approach could improve tumor control and quality of life for patients with locally advanced NPC.

How similar studies have gone: Prior studies using immune checkpoint inhibitors with chemoradiation show potential benefits in NPC, but this specific combination including Omega-3 is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.
* 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).

Exclusion Criteria:

* 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).
* 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.

Where it's running

  • Affiliated Hospital of Guangdong Medical University
    Zhanjiang, Guangdong, China
    Recruiting
  • The Second Affiliated Hospital of Guangdong Medical University
    Zhanjiang, Guangdong, China
    Recruiting
  • Guangdong Nongken Central Hospital
    Zhanjiang, Guangdong, China
    Not yet recruiting

Study contacts

  • Principal investigator: Haiqing Luo, doctor — Guangdong Medical University Affiliated Hospital
  • Study coordinator: Haiqing Luo, doctor
  • Email: hqluo@126.com
  • Phone: 8613729196345

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.