NCT06749899 QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.
| NCT ID | NCT06749899 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-Sen University Cancer Center |
| Condition | Nasopharyngeal Cancinoma (NPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 580 participants |
| Start Date | 2025-05-04 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 580 participants in total. It began in 2025-05-04 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The trial aimed to compare QL1706 combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in High-risk Locoregionally-Advanced Nasopharyngeal Carcinoma (LANPC).
Eligibility 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.
Contact & Investigator
Jun Ma, M.D.
PRINCIPAL INVESTIGATOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT06749899 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Nasopharyngeal Cancinoma (NPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06749899 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 580 participants.
Is NCT06749899 currently recruiting?
Yes, NCT06749899 is actively recruiting participants. Contact the research team at majun2@mail.sysu.edu.cn for enrollment information.
Where is the NCT06749899 trial being conducted?
This trial is being conducted at Fuzhou, China, Dongguan, China, Foshan, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT06749899 clinical trial?
NCT06749899 is sponsored by Sun Yat-Sen University Cancer Center. The principal investigator is Jun Ma, M.D. at Sun Yat-sen University. The trial plans to enroll 580 participants.