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Nasopharyngeal Cancinoma (NPC)Phase 3NCT06749899

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

A Phase 3 study testing QL1706, Gemcitabine and Cisplatin in people with Nasopharyngeal Cancinoma (NPC) and Nasopharyngeal Cancer, run by Sun Yat-Sen University Cancer Center at 19 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
QL1706, Gemcitabine and Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
580 participants
Where
19 sitesChina
Study dates
4 May 2025to 1 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 exclusion criteria 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, laboratory testing, and other protocol-related requirements.
  • 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).

Who cannot join

  • 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 one year prior should also be excluded, unless they received confirmed and regular anti-tuberculosis treatment.
  • 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.
  • 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.
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  • 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 laboratory values, or other psychological, familial, or social risk factors.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jun Ma, M.D. contact

+862087343469

majun2@mail.sysu.edu.cn

Rui Guo, M.D. contact

guorui@sysucc.org.cn

19 sites in 1 country

China19 sites, 19 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Ya-Qian Han

    Not yet recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan

    Liang-Fang Shen, M.D.

    Not yet recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610001

    Shi-chuan Zhang, M.D.

    Not yet recruiting

  • Dongguan People's Hospital

    Dongguan, Guangdong

    Zhi-Gang Liu

    Not yet recruiting

  • First People's Hospital of Foshan

    Foshan, Guangdong

    Ning Zhang

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Fujian, Xiamen, 361000

    Qin Lin, M.D.

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Chuan-Ben Chen

    Su-Fang Qiu

    Not yet recruiting

  • Guangzhou Panyu Central Hospital

    Guangzhou, Guangdong, 510060

    Guo-Rong Zou

    Not yet recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Jun Ma, M.D., +862087343469, majun2@mail.sysu.edu.cn

    Recruiting

  • Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou

    Feng Jin, M.D.

    Not yet recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210000

    Xia He, M.D.

    Not yet recruiting

  • Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

    Xiao-Dong Zhu, M.D.

    Not yet recruiting

  • The Eye and ENT Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200000

    Xiao-Shen Wang, M.D.

    Not yet recruiting

  • Tianjin Medical University Cancer Institute ＆ Hospital

    Tianjin, Tianjin Municipality, 30000

    Pei-guo Wang, M.D.

    Not yet recruiting

  • Hubei Province Cancer Hosiptal

    Wuhan, Hubei, 430000

    De-Sheng Hu, M.D.

    Not yet recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430000

    Xiang-Pan Li, M.D.

    Not yet recruiting

  • Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Guang-Yuan Hu, M.D.

    Not yet recruiting

  • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Kun-Yu Yang, M.D.

    Not yet recruiting

  • Zhongshan People's Hospital

    Zhongshan, Guangdong

    Feng Lei

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

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).

Read the 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.

Being tested
QL1706, Gemcitabine, Cisplatin, Intensity-modulated radiotherapy
Keywords
Immunotherapy, PD-1/CTLA-4 Bi-specific Antibody, Chemoradiotherapy
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QL1706Drug

    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.

  • GemcitabineDrug

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

  • CisplatinDrug

    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 radiotherapyRadiation

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

Study groups in NCT06749899
Study groupRoleWhat they receive
QL1706 ArmExperimentalPatients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. 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.
Receives: Drug: QL1706; Drug: Gemcitabine; Drug: Cisplatin; Radiation: Intensity-modulated radiotherapy
Chemoradiation ArmActive comparatorPatients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT.
Receives: Drug: Gemcitabine; Drug: Cisplatin; Radiation: Intensity-modulated radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Failure-free survival (FFS) in intention-to-treat population

    Multiple endpoint 1: calculated from randomization to the date of locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.

    Measured: 3 years

  2. Overall survival (OS) in intention-to-treat population

    Multiple endpoint 2: calculated from randomization to the date of death from any cause.

    Measured: 5 years

Secondary outcomes (8)

  1. Failure-free survival (FFS) in per-protocol population

    calculated from randomization to the date of locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.

    Measured: 3 years

  2. Overall survival (OS) in per-protocol population

    calculated from randomization to the date of death from any cause.

    Measured: 3 years

  3. Locoregional recurrence-free survival (LRRFS)

    calculated from randomization to the date of locoregional persistence or 1st locoregional recurrence.

    Measured: 3 years

  4. Distant metastasis-free survival (DMFS)

    calculated from randomization to the date of first distant metastasis.

    Measured: 3 years

  5. Adverse events (AEs) and serious adverse events (SAEs)

    Graded according to CTCAE V5.0.

    Measured: 3 years

  6. Quality of life (QoL)

    The change of QoL from randomization to the start of radiotherapy, the end of radiotherapy, 13-16 weeks after radiotherapy, 2 years and 3 years after randomization. The EORTC QoL questionnaire-C30 (EORTC QLQ-C30）version 3.0 will be used. This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual.

    Measured: week 1, 20, 40, 64

  7. Failure-free survival (FFS) within different subgroups

    analyses for FFS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (≤4000copies/ml vs. >4000copies/ml), different PD-L1 expression levels, age, gender, performance status, T category, N category, and stage (III vs. IVA).

    Measured: 3 years

  8. Tumor response

    Evaluation of tumor response as CR, PR, SD, PD, NA by clinicians

    Measured: Every 6 weeks（the time of completion of induction chemotherapy, radiotherapy, and adjuvnt immunotherapy; from the date of enrollment until the date of the last time that tumorimaging and assessment of disease has been done, assessed up to 74 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2024
  2. Study start4 May 2025
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
580 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06749899
Sponsor's protocol ID
2024-FXY-409-FLK
Status last verified
Dec 2024
First submitted
19 Dec 2024
Last updated
22 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Complete de-identified patient data set will be submitted onto an online platform.

Publications

  • Hsu C, Lee SH, Ejadi S, Even C, Cohen RB, Le Tourneau C, Mehnert JM, Algazi A, van Brummelen EMJ, Saraf S, Thanigaimani P, Cheng JD, Hansen AR. Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 20;35(36):4050-4056. doi: 10.1200/JCO.2017.73.3675. Epub 2017 Aug 24.

    PubMed 28837405

  • Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.

    PubMed 37158938

  • Zhang Y, Chen L, Hu GQ, Zhang N, Zhu XD, Yang KY, Jin F, Shi M, Chen YP, Hu WH, Cheng ZB, Wang SY, Tian Y, Wang XC, Sun Y, Li JG, Li WF, Li YH, Tang LL, Mao YP, Zhou GQ, Sun R, Liu X, Guo R, Long GX, Liang SQ, Li L, Huang J, Long JH, Zang J, Liu QD, Zou L, Su QF, Zheng BM, Xiao Y, Guo Y, Han F, Mo HY, Lv JW, Du XJ, Xu C, Liu N, Li YQ, Chua MLK, Xie FY, Sun Y, Ma J. Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma. N Engl J Med. 2019 Sep 19;381(12):1124-1135. doi: 10.1056/NEJMoa1905287. Epub 2019 May 31.

    PubMed 31150573

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QL1706, Gemcitabine and Cisplatin in people with Nasopharyngeal Cancinoma (NPC) and Nasopharyngeal Cancer, run by Sun Yat-Sen University Cancer Center at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun Ma, M.D. (+862087343469, majun2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure-free survival (FFS) in intention-to-treat population (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06749899, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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