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Combination of QL1706 and Chemoradiotherapy for Advanced Nasopharyngeal Cancer

QL1706 (Iparomlimab and Tuvonralimab Injection,PD-1/ CTLA-4 Bi-specific Antibody) Combined With Chemoradiotherapy Versus Chemoradiotherapy Alone in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma：A Randomized, Controlled, Multicenter Phase III Clinical Study.

Phase 3 Interventional Sun Yat-sen University · NCT06749899

This study is testing if adding a new drug called QL1706 to standard chemotherapy and radiation can help people with advanced nasopharyngeal cancer live better and longer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment580 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorSun Yat-sen University Academic / other
Drugs / interventionsepalurilimab, tovorolimab, prednisone, chemotherapy, radiation
Locations19 sites (Fuzhou, Fujian and 18 other locations)
Trial IDNCT06749899 on ClinicalTrials.gov

What this trial studies

This trial compares the effectiveness of QL1706, a PD-1/CTLA-4 bi-specific antibody, combined with induction chemotherapy and concurrent chemoradiotherapy against the same chemotherapy and radiotherapy regimen alone in patients with high-risk locoregionally-advanced nasopharyngeal carcinoma. Participants will be randomized to receive either the combination treatment or standard treatment, with all patients undergoing intensity-modulated radiotherapy. The study aims to evaluate the potential benefits of adding QL1706 to the treatment regimen in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with histologically confirmed non-keratinizing nasopharyngeal carcinoma at specific advanced stages.

Not a fit: Patients outside the age range of 18 to 65 or those with non-confirmed or different types of nasopharyngeal carcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promise in using immunotherapy in combination with chemoradiotherapy for various cancers, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

1. Age ≥18 and ≤65 years
2. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
3. Tumor staged as T4N1 and T1-4N2-3 (AJCC 9th)

   * Stage II: T1-3N2
   * Stage III: T1-4N3, T4N1-2
4. Eastern Cooperative Oncology Group performance score of 0-11.
5. Adequate marrow function: white blood cell count \> 4 × 10⁹/Lhemoglobin \>90g/L and platelet count \>100×10⁹/L
6. Adequate hepatic and renal function：

   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
   * Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×ULN
   * Alkaline phosphatase ≤ 2.5 × ULN
   * clearance rate ≥ 60 ml/min
7. Other laboratory and clinical criteria

   * Normal thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG)
   * For patients aged \>50 years with a history of smoking, normal pulmonary function test (PFT) results are required
   * For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits
8. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.
9. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).

Exclusion Criteria

1. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \>1×103 copies/mL, positive for anti-hepatitis C virus (HCV) antibody , positive for anti-hepatitis C virus (HCV) antibody
2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received confirmed and regular anti-tuberculosis treatment.
4. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.
5. Thymic epithelial tumors (TETs), including thymoma, thymic carcinoma, and thymic neuroendocrine tumors (NETTs).
6. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.
7. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.
8. Uncontrolled cardiac conditions, such as:

   * Heart failure with New York Heart Association (NYHA) classification ≥ Class II;
   * Unstable angina;
   * History of myocardial infarction within the past year;
   * Supraventricular or ventricular arrhythmias requiring treatment or intervention
9. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)
10. History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
11. Known hypersensitivity to macromolecule protein products or any component of QL1706.
12. Active infections requiring systemic treatment within 1 week prior to enrollment.
13. Administration of live vaccines within 30 days prior to the first dose of epalurilimab-tovorolimab.
14. History of organ transplantation or hematopoietic stem cell transplantation.
15. Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors.

Where this trial is running

Fuzhou, Fujian and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Nasopharyngeal CancinomaNasopharyngeal CancerImmunotherapyPD-1/CTLA-4 Bi-specific AntibodyChemoradiotherapy
Last reviewed 2026-06-13 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.