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New treatment option for Nasopharyngeal Cancinoma (NPC)
Official title QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.
ClinicalTrials.gov ID: NCT06749899
What this study is testing
What is QL1706?
QL1706 is an investigational medicine, being studied as a potential treatment for nasopharyngeal cancinoma (npc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age ≥18 and ≤65 years
- Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
- Tumor staged as T4N1 and T1-4N2-3 (AJCC 9th)
- Stage II: T1-3N2
- Stage III: T1-4N3, T4N1-2
You likely can't join if
- listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with...
- 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...
- Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of...
- 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-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
- Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status...
See the full eligibility criteria
- Age ≥18 and ≤65 years
- Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
- Tumor staged as T4N1 and T1-4N2-3 (AJCC 9th)
- Stage II: T1-3N2
- Stage III: T1-4N3, T4N1-2
- Eastern Cooperative Oncology Group performance score of 0-11.
- Adequate marrow function: white blood cell count \> 4 × 10⁹/Lhemoglobin \>90g/L and platelet count \>100×10⁹/L
- 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
- 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
- listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits
- 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...
- 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...
- 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
- Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
- 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...
- Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma...
- Thymic epithelial tumors (TETs), including thymoma, thymic carcinoma, and thymic neuroendocrine tumors (NETTs).
- History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.
- 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.
- 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
- Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)
- History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
- Known hypersensitivity to macromolecule protein products or any component of QL1706.
- Active infections requiring systemic treatment within 1 week prior to enrollment.
- Administration of live vaccines within 30 days prior to the first dose of epalurilimab-tovorolimab.
- History of organ transplantation or hematopoietic stem cell transplantation.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Dongguan, Guangdong, China
- Foshan, Guangdong, China
- Guangzhou, Guangdong, China
- Zhongshan, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Fujian, Xiamen, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Dongguan, Guangdong, China; Foshan, Guangdong, China; Guangzhou, Guangdong, China; Zhongshan, Guangdong, China; Nanning, Guangxi, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.