Immunotherapy combo trial aims to boost survival in head and neck cancer
NCT ID NCT07362979
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing whether adding the immunotherapy drug Toripalimab to different platinum-based chemotherapy regimens, followed by standard chemoradiotherapy, can improve outcomes for people with locally advanced nasopharyngeal cancer. About 243 participants will be randomly assigned to one of three treatment combinations. The goal is to find which combination offers the best chance of preventing the cancer from returning or spreading.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toripalimab (an immunotherapy drug) combined with platinum-based chemotherapy (gemcitabine, cisplatin, or nab-paclitaxel)
- What this could lead to
- If successful, this could identify a more effective treatment combination for advanced nasopharyngeal cancer, potentially improving survival rates.
- What could go wrong
- This is an early phase II trial with a moderate size (243 participants). Results may not confirm benefit, and side effects from combining immunotherapy with chemotherapy can be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 243 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age between 18 and 70 years, male or non-pregnant female. 2. Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III). 3. Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant metastasis (M0). 4. ECOG performance status score of 0 or 1. 5. Adequate hematological function: Hemoglobin (HGB)≥90g/L, Absolute Neutrophil Count (ANC) ≥ 1.5\*10\^9/L, and Platele (PLT) ≥100\*10\^9/L. 6. Adequate hepatic function: ALT and AST≤2.5\*Upper Limit of Normal (ULN), total bilirubin ≤2.0\*ULN, and serum albumin≥30g/L. 7. Adequate renal function: Serum creatinine ≤ 1.5\*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula). 8. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \*ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening). Exclusion Criteria: 1. Patients with nasopharyngeal carcinoma presenting with recurrence or distant metastasis. 2. Pathologically confirmed diagnosis of keratinizing squamous cell carcinoma (WHO Type I). 3. Prior history of radiotherapy or systemic chemotherapy. 4. Women who are pregnant, lactating, or of childbearing potential not employing effective contraception. 5. HIV-positive status. 6. History of other malignancies (except for cured basal cell carcinoma or carcinoma in situ of the cervix). 7. Patients previously treated with immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors). 8. Patients with immunodeficiency diseases or a history of organ transplantation. 9. Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks prior. 10. Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function. 11. Concurrent use of other investigational drugs or current participation in another clinical trial. 12. Patients who refuse or are unable to provide signed informed consent for trial participation. 13. Patients with personality or psychiatric disorders, or those lacking legal capacity or with limited legal capacity. 14. Hepatitis B surface antigen (HBsAg) positive with peripheral blood Hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000 copies/ml. 15. Patients with positive Hepatitis C virus (HCV) antibody test results are eligible only if the HCV ribonucleic acid (RNA) polymerase chain reaction test result is negative. 16. Arterial or venous thrombotic events within 6 months prior to screening initiation, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism. 17. Known history of active tuberculosis (TB). Subjects suspected of having active TB must be evaluated and ruled out via chest X-ray, sputum examination, and clinical signs and symptoms. 21.Any other severe, uncontrolled medical condition, infection, or treatment contraindication, or any other condition that, in the investigator's judgment, may pose a risk for receiving the investigational drug, or may interfere with the assessment of the investigational drug, subject safety, or interpretation of the study results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Hospital of Guangdong Medical University
RECRUITINGZhanjiang, Guangdong, China
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Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen
RECRUITINGShenzhen, Guangdong, China
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Dongguan People's Hospital
RECRUITINGDongguan, Guangdong, China
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Platinum-Free regimen beat nasopharyngeal carcinoma?
- Could a baking soda rinse tame radiation mouth sores?
- New drug duo aims to keep advanced nasopharyngeal cancer in check
- New surveillance strategy aims to catch residual cancer early in High-Risk nasopharyngeal carcinoma
- New combo strategy aims to catch and remove leftover cancer after radiation