Nasopharyngeal Cancinoma (NPC)Phase 3NCT07385079
Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk Nasopharyngeal Carcinoma
A Phase 3 study testing Anlotinib Hydrochloride Capsules, Gemcitabine (GEM) and Cisplatin in people with Nasopharyngeal Cancinoma (NPC) and Nasopharyngeal Cancer, run by Sun Yat-sen University.
Trial summary
This trial aimed to evaluate the efficacy of anlotinib hydrochloride combined with benmelstobart, induction chemotherapy, and concurrent chemoradiotherapy (IC+CCRT), versus a regimen of benmelstobart plus IC+CCRT, in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (LANPC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC), Nasopharyngeal Cancer
- What is being tested?
- Anlotinib Hydrochloride Capsules, Gemcitabine (GEM) and Cisplatin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Jan 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 T4N2 and T1-4N3 (AJCC 9th)
- Eastern Cooperative Oncology Group performance score of 0-11.
- Adequate marrow function: white blood cell count > 4 × 10⁹/L hemoglobin >90g/L and platelet count >100×10⁹/L
- Adequate hepatic and renal function：
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- 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.
- 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.
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- 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 benmelstobart.
- Active infections requiring systemic treatment within 1 week prior to enrollment.
- Administration of live vaccines within 30 days prior to the first dose of anlotinib hydrochloride.
- History of organ transplantation or hematopoietic stem cell transplantation.
- Presence of clinically significant bleeding symptoms or a definite hemorrhagic tendency; specifically, cases with a high risk of bleeding from local recurrence, or those within one year post-radiotherapy assessed to have a high risk of necrosis, must be excluded.
- History of hypertension that remains poorly controlled with medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
- Urinalysis showing urine protein ≥ ++, confirmed by 24-hour urine protein quantification ≥1.0 g.
- Factors significantly affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Multicenter, Phase 3 Trial of Anlotinib Plus Immunochemoradiotherapy vs Immunochemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma
This trial aimed to evaluate the efficacy of anlotinib hydrochloride combined with benmelstobart, induction chemotherapy, and concurrent chemoradiotherapy (IC+CCRT), versus a regimen of benmelstobart plus IC+CCRT, in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (LANPC).
Read the detailed description
This trial will enroll patients with locoregionally advanced nasopharyngeal carcinoma (LANPC) staged as T4N2 or T1-4N3 (AJCC 9th edition). Participants will be randomized 1:1 to either the control or experimental regimen. The control regimen consists of three cycles of induction chemotherapy (gemcitabine, cisplatin, and benmelstobart), followed by concurrent cisplatin-based chemoradiotherapy and 9 cycles of benmelstobart as adjuvant therapy. The experimental group will receive the same regimen plus anlotinib hydrochloride during the induction chemotherapy phase. All patients will receive intensity-modulated radiotherapy (IMRT). In the experimental group, anlotinib hydrochloride will be administered on days 1-14 of each 3-week induction cycle for three cycles.
- Being tested
- Anlotinib Hydrochloride Capsules, Gemcitabine (GEM), Cisplatin, Intensity-modulated radiotherapy, Benmelstobart
- Keywords
- anlotinib hydrochloride, PD-L1 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.
Anlotinib Hydrochloride CapsulesDrug
Anlotinib hydrochloride (10mg, d1-d14) will be given every 3 weeks for 3 cycles in induction chemotherapy.
Gemcitabine (GEM)Drug
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.
BenmelstobartDrug
Benmelstobart 1200mg 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.
| Study group | Role | What they receive |
|---|---|---|
| anlotinib hydrochloride Arm | Experimental | Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), and benmelstobart (1200mg, d1) 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. Anlotinib hydrochloride (10mg, d1-d14) will be given every 3 weeks for 3 cycles in induction chemotherapy. Subsequently, adjuvant therapy with benmelstobart (1200 mg, d1) will be initiated for a total of 9 cycles. Receives: Drug: Anlotinib Hydrochloride Capsules; Drug: Gemcitabine (GEM); Drug: Cisplatin; Radiation: Intensity-modulated radiotherapy; Drug: Benmelstobart |
| PD-L1+Chemoradiation Arm | Active comparator | Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), and benmelstobart (1200mg, d1) 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. Adjuvant therapy with benmelstobart (1200 mg, d1) will be initiated for a total of 9 cycles. Receives: Drug: Gemcitabine (GEM); Drug: Cisplatin; Radiation: Intensity-modulated radiotherapy; Drug: Benmelstobart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival (FFS)
From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first
Measured: 3 year
Secondary outcomes (7)
Tumor response
Evaluation of tumor response as CR, PR, SD, PD, NA by clinicians
Measured: the time of completion of induction chemotherapy, radiotherapy, and adjuvant 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 62 weeks
Overall survival (OS)
From date of randomization until the date of death from any cause, whichever came first
Measured: 3 years
Distant metastasis-free survival (DMFS)
From date of randomization until the date of first documented distant metastasis, whichever occurred first.
Measured: 3 years
Locoregional recurrence-free survival (LRRFS)
From date of randomization until the date of first documented locoregional recurrence, whichever occurred first.
Measured: 3 years
Adverse events (AEs) and serious adverse events (SAEs)
Graded according to CTCAE V5.0.
Measured: 3 years
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. For the functional scales and the global health status scale, a higher score represents a better level of functioning or quality of life. For the symptom scales, a higher score indicates a greater severity of symptoms.
Measured: week 1, 6, 24, 60, 72
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ma, MD, Sun Yat-sen University
- Investigators
- Jun Ma, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385079
- Sponsor's protocol ID
- 2025-FXY-257-FLK
- Status last verified
- Jan 2026
- First submitted
- 23 Sep 2025
- Last updated
- 3 Feb 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Phase 3 Trial of Anlotinib Plus Immunochemoradiotherapy vs Immunochemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07385079
- Acronym / sponsor ID
- 2025-FXY-257-FLK
- Keywords
- anlotinib hydrochloride, PD-L1 antibody, chemoradiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aimed to evaluate the efficacy of anlotinib hydrochloride combined with benmelstobart, induction chemotherapy, and concurrent chemoradiotherapy (IC+CCRT), versus a regimen of benmelstobart plus IC+CCRT, in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (LANPC).
Detailed description
This trial will enroll patients with locoregionally advanced nasopharyngeal carcinoma (LANPC) staged as T4N2 or T1-4N3 (AJCC 9th edition). Participants will be randomized 1:1 to either the control or experimental regimen. The control regimen consists of three cycles of induction chemotherapy (gemcitabine, cisplatin, and benmelstobart), followed by concurrent cisplatin-based chemoradiotherapy and 9 cycles of benmelstobart as adjuvant therapy. The experimental group will receive the same regimen plus anlotinib hydrochloride during the induction chemotherapy phase. All patients will receive intensity-modulated radiotherapy (IMRT). In the experimental group, anlotinib hydrochloride will be administered on days 1-14 of each 3-week induction cycle for three cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anlotinib hydrochloride Arm | Experimental | Drug: Anlotinib Hydrochloride Capsules, Drug: Gemcitabine (GEM), Drug: Cisplatin, Radiation: Intensity-modulated radiotherapy, Drug: BenmelstobartPatients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), and benmelstobart (1200mg, d1) 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. Anlotinib hydrochloride (10mg, d1-d14) will be given every 3 weeks for 3 cycles in induction chemotherapy. Subsequently, adjuvant therapy with benmelstobart (1200 mg, d1) will be initiated for a total of 9 cycles. |
| PD-L1+Chemoradiation Arm | Active comparator | Drug: Gemcitabine (GEM), Drug: Cisplatin, Radiation: Intensity-modulated radiotherapy, Drug: BenmelstobartPatients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), and benmelstobart (1200mg, d1) 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. Adjuvant therapy with benmelstobart (1200 mg, d1) will be initiated for a total of 9 cycles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥18 and ≤65 years
- Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
- Tumor staged as T4N2 and T1-4N3 (AJCC 9th)
- Eastern Cooperative Oncology Group performance score of 0-11.
- Adequate marrow function: white blood cell count > 4 × 10⁹/L hemoglobin >90g/L and platelet count >100×10⁹/L
Key exclusion criteria (22 listed)
- 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.
- History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib Hydrochloride CapsulesAnlotinib hydrochloride (10mg, d1-d14) will be given every 3 weeks for 3 cycles in induction chemotherapy. | Drug | anlotinib hydrochloride Arm |
| Gemcitabine (GEM)Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation. | Drug | PD-L1+Chemoradiation Arm, anlotinib hydrochloride Arm |
| CisplatinInduction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation | Drug | PD-L1+Chemoradiation Arm, anlotinib hydrochloride Arm |
| Intensity-modulated radiotherapyDefinitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions. | Radiation | PD-L1+Chemoradiation Arm, anlotinib hydrochloride Arm |
| BenmelstobartBenmelstobart 1200mg 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. | Drug | PD-L1+Chemoradiation Arm, anlotinib hydrochloride Arm |
Primary outcome
Failure-free survival (FFS)
Time frame: 3 year
From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first
7 secondary outcomes
Tumor response
Time frame: the time of completion of induction chemotherapy, radiotherapy, and adjuvant 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 62 weeks
Overall survival (OS)
Time frame: 3 years
Distant metastasis-free survival (DMFS)
Time frame: 3 years
Locoregional recurrence-free survival (LRRFS)
Time frame: 3 years
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: 3 years
Quality of life (QoL)
Time frame: week 1, 6, 24, 60, 72
Failure-free survival (FFS) within different subgroups
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No. Complete de-identified patient data set will be submitted onto an online platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Ma, M.D. principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anlotinib Hydrochloride Capsules, Gemcitabine (GEM) and Cisplatin in people with Nasopharyngeal Cancinoma (NPC) and Nasopharyngeal Cancer, run by Sun Yat-sen University.
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 16 inclusion and 22 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: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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) (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026.