Nasopharyngeal Cancinoma (NPC)Phase 2RAPIDNCT07904819
Risk-Adapted Anlotinib and PD-L1 for Locoregionally Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing Anlotinib Hydrochloride Capsules, Benmelstobart and Gemcitabine (GEM) in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of a risk-adapted treatment strategy incorporating induction therapy (Gemcitabine + Cisplatin) with Anlotinib plus Benmelstobart, followed by treatment allocation based on post-induction plasma cell-free Epstein-Barr virus DNA (cfEBV DNA) status and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Anlotinib Hydrochloride Capsules, Benmelstobart and Gemcitabine (GEM)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Dec 2033
- Phase
- Phase 2
- 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 at diagnosis, regardless of sex.
- Previously untreated nasopharyngeal carcinoma histologically confirmed as non-keratinizing carcinoma according to the World Health Organization (WHO) classification.
- Locoregionally advanced nasopharyngeal carcinoma classified as stage II or III, excluding T3N0-1 disease, according to the 9th edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) clinical staging system.
- Eastern Cooperative Oncology Group performance score of 0-1.
- Adequate marrow function: white blood cell count > 4 × 10⁹/L hemoglobin >90g/L and platelet count >100×10⁹/L
- Adequate hepatic and renal function：
Show all 17Show fewer
- 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).
- Positive plasma Epstein-Barr virus (EBV) DNA before initiation of treatment (> 0 copies/mL).
Who cannot join
- Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA >1×10^3 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.
Show all 22Show fewer
- 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 Risk-Adapted, Multicenter, Prospective Clinical Trial of Anlotinib Combined With a PD-L1 Inhibitor in Locoregionally Advanced Nasopharyngeal Carcinoma
The purpose of this study is to evaluate the efficacy and safety of a risk-adapted treatment strategy incorporating induction therapy (Gemcitabine + Cisplatin) with Anlotinib plus Benmelstobart, followed by treatment allocation based on post-induction plasma cell-free Epstein-Barr virus DNA (cfEBV DNA) status and radiographic response in patients with locoregionally advanced nasopharyngeal carcinoma. All participants will receive three cycles of induction therapy (Gemcitabine + Cisplatin) with Anlotinib plus Benmelstobart. After induction therapy, participants with cfEBV DNA clearance and a complete or partial response will be classified as low risk and receive intensity-modulated radiotherapy alone, followed by adjuvant Benmelstobart. Participants without cfEBV DNA clearance or with stable or progressive disease will be classified as high risk and receive intensity-modulated radiotherapy with concurrent cisplatin, followed by adjuvant Benmelstobart and capecitabine. The primary objectives are to evaluate the post-induction therapy complete response rate in the overall study population and event-free survival in the high-risk group.
Read the detailed description
This is a multicenter, prospective study evaluating a biomarker- and response-guided risk-adapted treatment strategy for locoregionally advanced nasopharyngeal carcinoma. All participants will receive three cycles of induction therapy (Gemcitabine + Cisplatin) with Anlotinib, a multi-targeting tyrosine kinase inhibitor, plus the PD-L1 inhibitor Benmelstobart. Risk assignment will be performed after completion of induction therapy using both plasma cell-free Epstein-Barr virus DNA (cfEBV DNA) status and radiographic tumor response. Participants with undetectable cfEBV DNA and a complete or partial response after induction therapy will be assigned to the low-risk group. These participants will then receive intensity-modulated radiotherapy without concurrent cisplatin, followed by adjuvant Benmelstobart. Participants with detectable cfEBV DNA after induction therapy, or whose best radiographic response is stable or progressive disease, will be assigned to the high-risk group. These participants will receive intensity-modulated radiotherapy with concurrent cisplatin, followed by adjuvant Benmelstobart and capecitabine. The study has two primary objectives: to evaluate the complete response rate after induction therapy in the overall study population and to evaluate event-free survival in the higher-risk group. Secondary evaluations include overall survival, distant metastasis-free survival, locoregional recurrence-free survival, cfEBV DNA clearance after induction therapy, safety, tolerability, and patient-reported quality of life.Exploratory analyses will investigate potential prognostic and treatment-response biomarkers in tumor tissue, blood, and stool samples. Clinical outcomes will also be explored across subgroups defined by age, sex, baseline cfEBV DNA level, percentage reduction or clearance of cfEBV DNA, clinical stage, and other relevant prognostic factors.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Anlotinib Hydrochloride Capsules, Benmelstobart, Gemcitabine (GEM), Cisplatin (100mg/m2), Intensity-Modulated Radiotherapy
- Keywords
- anlotinib hydrochloride, PD-L1 antibody, Risk-Adapted therapy, chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib Hydrochloride CapsulesDrug
Induction Therapy: Anlotinib hydrochloride 10mg, oral administration, Day1-14, (3 cycles, Q3W)
BenmelstobartDrug
Induction Therapy: Benmelstobart 1200 mg, intravenous infusion, Day 1 (3 cycles, Q3W); Adjuvant Therapy: Benmelstobart 1200 mg, intravenous infusion, Day 1 (5 cycles, Q3W)
Gemcitabine (GEM)Drug
Induction Therapy: Gemcitabine 1g/m2, intravenous infusion, Day 1\&8 (3 cycles, Q3W)
Cisplatin (100mg/m2)Drug
Concurrent Chemoradiotherapy: Cisplatin 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W)
Intensity-Modulated RadiotherapyRadiation
70 Gy in 33 fractions, once daily, 5 days per week
CapecitabineDrug
Adjuvant Therapy: Capecitabine 650 mg/m², orally twice daily, Days 1-21 (17 cycles, Q3W)
Cisplatin (80 mg/m2)Drug
Induction Therapy: Cisplatin 80 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W);
| Study group | Role | What they receive |
|---|---|---|
| Low-Risk Group | Experimental | Participants with undetectable plasma cfEBV DNA and a radiographic complete response or partial response after three cycles of induction therapy [Gemcitabine, 1g/m², intravenous infusion, Day 1 \& 8 + Cisplatin, 80mg/m², intravenous infusion, Day 1 + Anlotinib 10 mg, oral administration, Day 1-14 + Benmelstobart 1200 mg, intravenous infusion, Day 1; 3 cycles, Q3W ] are classified as low risk and receive the following treatment: Radiotherapy Alone: Intensity-modulated radiotherapy (IMRT), 70 Gy in 33 fractions, once daily, 5 days per week; Adjuvant Immunotherapy (5 cycles, Q3W): Benmelstobart 1200 mg, intravenous infusion, Day 1. Receives: Drug: Anlotinib Hydrochloride Capsules; Drug: Benmelstobart; Drug: Gemcitabine (GEM); Radiation: Intensity-Modulated Radiotherapy; Drug: Cisplatin (80 mg/m2) |
| High-Risk Group | Experimental | Participants with detectable plasma cfEBV DNA or a radiographic response of stable disease or progressive disease after three cycles of induction therapy [Gemcitabine, 1g/m², intravenous infusion, Day 1 \& 8 + Cisplatin, 80mg/m², intravenous infusion, Day 1 + Anlotinib 10 mg, oral administration, Day 1-14 + Benmelstobart 1200 mg, intravenous infusion, Day 1; 3 cycles, Q3W ] are classified as high risk and receive the following treatment: Concurrent Chemoradiotherapy (CCRT): IMRT, 70 Gy in 33 fractions, once daily, 5 days per week + Cisplatin 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W); Adjuvant Therapy: Benmelstobart 1200 mg, intravenous infusion, Day 1 (5 cycles, Q3W) + Capecitabine 650 mg/m², orally twice daily, Days 1-21 (17 cycles, Q3W). Receives: Drug: Anlotinib Hydrochloride Capsules; Drug: Benmelstobart; Drug: Gemcitabine (GEM); Drug: Cisplatin (100mg/m2); Radiation: Intensity-Modulated Radiotherapy; Drug: Capecitabine; Drug: Cisplatin (80 mg/m2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-induction Therapy Complete Response Rate (post-IT CRR)
The proportion of patients achieving complete response following induction therapy
Measured: Within 9 to 21 days after the last dose of induction therapy
Event-Free Survival (EFS) in the High-Risk Group
The time from the date of enrollment to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause.
Measured: 3 years & 5 years
Secondary outcomes (8)
Overall survival (OS)
From date of enrollment to date of death from any cause
Measured: 3 years & 5 years
Distant Metastasis-Free Survival (DMFS)
From the date of enrollment to the date of first documented distant metastasis or death from any cause, whichever occurs first.
Measured: 3 years & 5 years
Locoregional Recurrence-Free Survival (LRRFS)
From the date of enrollment to the date of first documented locoregional recurrence or death from any cause, whichever occurs first.
Measured: 3 years & 5 years
Adverse Events (AEs)
Graded according to CTCAE V5.0
Measured: 3 years & 5 years
Patient-Reported Adverse Events (PRO-CTCAE)
Patient-reported adverse events will be assessed using selected items from the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE™), Chinese version, administered at each treatment cycle. Patients will self-report and rate the severity of relevant adverse events throughout the study treatment period.
Measured: At the end of each treatment cycle (each cycle is 21 days), from Cycle 1 of induction therapy through Cycle 5 of adjuvant therapy
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Assesses general quality of life in cancer patients. Items are scored and linearly transformed to a 0-100 scale. For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate greater symptom burden.
Measured: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
EORTC Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35, version 1)
Assesses head and neck cancer-specific symptoms. Items are scored and linearly transformed to a 0-100 scale. Higher scores indicate more severe symptoms.
Measured: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N, Chinese version 4)
Assesses quality of life specific to head and neck cancer patients. Items are rated on a 0-4 scale and summed to a total score of 0-156. Higher scores indicate better quality of life.
Measured: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2033 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants receive the same induction therapy and are subsequently stratified into low- and high-risk groups according to post-induction cfEBV DNA status and radiographic response, with each group receiving its protocol-defined treatment.
- Masking
- None (open label)
- Enrolment
- 214 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904819
- Sponsor's protocol ID
- 2026-FXY-325-FLK
- Acronym
- RAPID
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Risk-Adapted, Multicenter, Prospective Clinical Trial of Anlotinib Combined With a PD-L1 Inhibitor in Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07904819
- Acronym / sponsor ID
- RAPID / 2026-FXY-325-FLK
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Keywords
- anlotinib hydrochloride, PD-L1 antibody, Risk-Adapted therapy, chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 29 Oct 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.
The purpose of this study is to evaluate the efficacy and safety of a risk-adapted treatment strategy incorporating induction therapy (Gemcitabine + Cisplatin) with Anlotinib plus Benmelstobart, followed by treatment allocation based on post-induction plasma cell-free Epstein-Barr virus DNA (cfEBV DNA) status and radiographic response in patients with locoregionally advanced nasopharyngeal carcinoma. All participants will receive three cycles of induction therapy (Gemcitabine + Cisplatin) with Anlotinib plus Benmelstobart. After induction therapy, participants with cfEBV DNA clearance and a complete or partial response will be classified as low risk and receive intensity-modulated radiotherapy alone, followed by adjuvant Benmelstobart. Participants without cfEBV DNA clearance or with stable or progressive disease will be classified as high risk and receive intensity-modulated radiotherapy with concurrent cisplatin, followed by adjuvant Benmelstobart and capecitabine. The primary objectives are to evaluate the post-induction therapy complete response rate in the overall study population and event-free survival in the high-risk group.
Detailed description
This is a multicenter, prospective study evaluating a biomarker- and response-guided risk-adapted treatment strategy for locoregionally advanced nasopharyngeal carcinoma. All participants will receive three cycles of induction therapy (Gemcitabine + Cisplatin) with Anlotinib, a multi-targeting tyrosine kinase inhibitor, plus the PD-L1 inhibitor Benmelstobart. Risk assignment will be performed after completion of induction therapy using both plasma cell-free Epstein-Barr virus DNA (cfEBV DNA) status and radiographic tumor response. Participants with undetectable cfEBV DNA and a complete or partial response after induction therapy will be assigned to the low-risk group. These participants will then receive intensity-modulated radiotherapy without concurrent cisplatin, followed by adjuvant Benmelstobart. Participants with detectable cfEBV DNA after induction therapy, or whose best radiographic response is stable or progressive disease, will be assigned to the high-risk group. These participants will receive intensity-modulated radiotherapy with concurrent cisplatin, followed by adjuvant Benmelstobart and capecitabine. The study has two primary objectives: to evaluate the complete response rate after induction therapy in the overall study population and to evaluate event-free survival in the higher-risk group. Secondary evaluations include overall survival, distant metastasis-free survival, locoregional recurrence-free survival, cfEBV DNA clearance after induction therapy, safety, tolerability, and patient-reported quality of life.Exploratory analyses will investigate potential prognostic and treatment-response biomarkers in tumor tissue, blood, and stool samples. Clinical outcomes will also be explored across subgroups defined by age, sex, baseline cfEBV DNA level, percentage reduction or clearance of cfEBV DNA, clinical stage, and other relevant prognostic factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants receive the same induction therapy and are subsequently stratified into low- and high-risk groups according to post-induction cfEBV DNA status and radiographic response, with each group receiving its protocol-defined treatment.
| Arm | Type | Receives |
|---|---|---|
| Low-Risk Group | Experimental | Drug: Anlotinib Hydrochloride Capsules, Drug: Benmelstobart, Drug: Gemcitabine (GEM), Radiation: Intensity-Modulated Radiotherapy, Drug: Cisplatin (80 mg/m2)Participants with undetectable plasma cfEBV DNA and a radiographic complete response or partial response after three cycles of induction therapy [Gemcitabine, 1g/m², intravenous infusion, Day 1 \& 8 + Cisplatin, 80mg/m², intravenous infusion, Day 1 + Anlotinib 10 mg, oral administration, Day 1-14 + Benmelstobart 1200 mg, intravenous infusion, Day 1; 3 cycles, Q3W ] are classified as low risk and receive the following treatment: Radiotherapy Alone: Intensity-modulated radiotherapy (IMRT), 70 Gy in 33 fractions, once daily, 5 days per week; Adjuvant Immunotherapy (5 cycles, Q3W): Benmelstobart 1200 mg, intravenous infusion, Day 1. |
| High-Risk Group | Experimental | Drug: Anlotinib Hydrochloride Capsules, Drug: Benmelstobart, Drug: Gemcitabine (GEM), Drug: Cisplatin (100mg/m2), Radiation: Intensity-Modulated Radiotherapy, Drug: Capecitabine, Drug: Cisplatin (80 mg/m2)Participants with detectable plasma cfEBV DNA or a radiographic response of stable disease or progressive disease after three cycles of induction therapy [Gemcitabine, 1g/m², intravenous infusion, Day 1 \& 8 + Cisplatin, 80mg/m², intravenous infusion, Day 1 + Anlotinib 10 mg, oral administration, Day 1-14 + Benmelstobart 1200 mg, intravenous infusion, Day 1; 3 cycles, Q3W ] are classified as high risk and receive the following treatment: Concurrent Chemoradiotherapy (CCRT): IMRT, 70 Gy in 33 fractions, once daily, 5 days per week + Cisplatin 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W); Adjuvant Therapy: Benmelstobart 1200 mg, intravenous infusion, Day 1 (5 cycles, Q3W) + Capecitabine 650 mg/m², orally twice daily, Days 1-21 (17 cycles, Q3W). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥18 and ≤65 years at diagnosis, regardless of sex.
- Previously untreated nasopharyngeal carcinoma histologically confirmed as non-keratinizing carcinoma according to the World Health Organization (WHO) classification.
- Locoregionally advanced nasopharyngeal carcinoma classified as stage II or III, excluding T3N0-1 disease, according to the 9th edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) clinical staging system.
- Eastern Cooperative Oncology Group performance score of 0-1.
- 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 >1×10^3 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 CapsulesInduction Therapy: Anlotinib hydrochloride 10mg, oral administration, Day1-14, (3 cycles, Q3W) | Drug | High-Risk Group, Low-Risk Group |
| BenmelstobartInduction Therapy: Benmelstobart 1200 mg, intravenous infusion, Day 1 (3 cycles, Q3W); Adjuvant Therapy: Benmelstobart 1200 mg, intravenous infusion, Day 1 (5 cycles, Q3W) | Drug | High-Risk Group, Low-Risk Group |
| Gemcitabine (GEM)Induction Therapy: Gemcitabine 1g/m2, intravenous infusion, Day 1\&8 (3 cycles, Q3W) | Drug | High-Risk Group, Low-Risk Group |
| Cisplatin (100mg/m2)Concurrent Chemoradiotherapy: Cisplatin 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W) | Drug | High-Risk Group |
| Intensity-Modulated Radiotherapy70 Gy in 33 fractions, once daily, 5 days per week | Radiation | High-Risk Group, Low-Risk Group |
| CapecitabineAdjuvant Therapy: Capecitabine 650 mg/m², orally twice daily, Days 1-21 (17 cycles, Q3W) | Drug | High-Risk Group |
| Cisplatin (80 mg/m2)Induction Therapy: Cisplatin 80 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W); | Drug | High-Risk Group, Low-Risk Group |
Primary outcome
Post-induction Therapy Complete Response Rate (post-IT CRR)
Time frame: Within 9 to 21 days after the last dose of induction therapy
The proportion of patients achieving complete response following induction therapy
Event-Free Survival (EFS) in the High-Risk Group
Time frame: 3 years & 5 years
The time from the date of enrollment to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause.
8 secondary outcomes
Overall survival (OS)
Time frame: 3 years & 5 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 3 years & 5 years
Locoregional Recurrence-Free Survival (LRRFS)
Time frame: 3 years & 5 years
Adverse Events (AEs)
Time frame: 3 years & 5 years
Patient-Reported Adverse Events (PRO-CTCAE)
Time frame: At the end of each treatment cycle (each cycle is 21 days), from Cycle 1 of induction therapy through Cycle 5 of adjuvant therapy
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Time frame: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
EORTC Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35, version 1)
Time frame: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N, Chinese version 4)
Time frame: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
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 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Nasopharyngeal Cancinoma (NPC)
Not yet recruitingPhase 2
Dynamic Plasma EBV DNA-Guided Risk-Adapted Treatment With Becotatug Vedotin (MRG003) Plus PD-1 Blockade in Locoregionally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC), Nasopharyngeal Cancer
RecruitingPhase 3
Prophylactic Nanocrystalline Megestrol Acetate Versus Placebo for Chemoradiotherapy-Related Anorexia in Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)
RecruitingPhase 1
Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors
Head & Neck Cancer, Nasopharyngeal Cancinoma (NPC)
Not yet recruitingPhase 2
Platinum-Free Regimen in Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)
Active, not recruitingPhase 3
Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.
Nasopharyngeal Cancinoma (NPC)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib Hydrochloride Capsules, Benmelstobart and Gemcitabine (GEM) in people with Nasopharyngeal Cancinoma (NPC), 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 17 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 29 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Post-induction Therapy Complete Response Rate (post-IT CRR) (time frame: Within 9 to 21 days after the last dose of induction therapy). 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?
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 29 Oct 2026.