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Clinical Trials in China / NCT06749899
Recruiting Phase 3

QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.

NCT06749899 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-Sen University Cancer Center
Phase
Phase 3
Started
2025-05-04
Last updated
2025-05-22

Condition(s) studied

Nasopharyngeal Cancinoma (NPC)Nasopharyngeal Cancer

Investigational drug(s) / intervention(s)

QL1706 →Gemcitabine →Cisplatin →Intensity-modulated radiotherapy

QL1706: QL1706 5mg/kg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 9 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively.

Gemcitabine: Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.

Cisplatin: Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

Intensity-modulated radiotherapy: Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Fujian Cancer Hospital Fuzhou Fujian Not Yet Recruiting
Dongguan People's Hospital Dongguan Guangdong Not Yet Recruiting
First People's Hospital of Foshan Foshan Guangdong Not Yet Recruiting
Guangzhou Panyu Central Hospital Guangzhou Guangdong Not Yet Recruiting
Sun Yat-Sen University Cancer Center Guangzhou Guangdong Recruiting
Zhongshan People's Hospital Zhongshan Guangdong Not Yet Recruiting
Cancer Hospital of Guangxi Medical University Nanning Guangxi Not Yet Recruiting
Cancer Hospital of Guizhou Medical University Guiyang Guizhou Not Yet Recruiting
Hubei Province Cancer Hosiptal Wuhan Hubei Not Yet Recruiting
Renmin Hospital of Wuhan University Wuhan Hubei Not Yet Recruiting
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei Not Yet Recruiting
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei Not Yet Recruiting
Hunan Cancer Hospital Changsha Hunan Not Yet Recruiting
Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
Jiangsu Cancer Hospital Nanjing Jiangsu Not Yet Recruiting
The Eye and ENT Hospital of Fudan University Shanghai Shanghai Municipality Not Yet Recruiting
Sichuan Cancer Hospital Chengdu Sichuan Not Yet Recruiting
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality Not Yet Recruiting
The First Affiliated Hospital of Xiamen University Fujian Xiamen Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06749899 on ClinicalTrials.gov ↗ ← All trials in China