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

RECRUITINGPHASE3

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

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.

NCT06749899•Sun Yat-Sen University Cancer Center

View on ClinicalTrials.gov

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).

Detailed Description

The trial plans to enroll patients with stage T4N1and T1-4N2-3 (AJCC 9th) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or the same regimen plus QL1706 in induction chemotherapy and adjuvant chemotherapy. All patients will receive intensity-modulated radiotherapy (IMRT). QL1706 will begin on day 1 of induction chemotherapy and continue every 3 weeks for 3 cycles in induction therapy and for 9 cycles in adjuvant therapy.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Exclusion Criteria

•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).
•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:
+11 more criteria

Locations (19)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

First People's Hospital of Foshan

Foshan, Guangdong, China

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Zhongshan People's Hospital

Zhongshan, Guangdong, China

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Hubei Province Cancer Hosiptal

Wuhan, Hubei, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Key Dates

Start Date

May 4, 2025

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2030

Last Updated

May 22, 2025

Enrollment

580

ESTIMATED participants

Conditions

Nasopharyngeal Cancinoma (NPC)Nasopharyngeal Cancer

Interventions

QL1706

DRUG

Gemcitabine

DRUG

Cisplatin

DRUG

Intensity-modulated radiotherapy

RADIATION

Contacts

Jun Ma, M.D.

CONTACT

+862087343469 majun2@mail.sysu.edu.cn

Rui Guo, M.D.

CONTACT

guorui@sysucc.org.cn

Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.

Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy

SBRT Combined With Nimotuzumab and Tislelizumab for Oligoprogressive Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of Immunotherapy

Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients

Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma

Adebrelimab and Chemoradiotherapy in High-risk LANPC