Nasopharyngeal CarcinomaPhase 3NCT06277050
Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma
A Phase 3 study testing Maintenance Therapy with Toripalimab and Capecitabine and Maintenance Therapy with Capecitabine in people with Nasopharyngeal Carcinoma and High-Risk Cancer, run by Jiangxi Provincial Cancer Hospital at 3 sites in China.
Trial summary
N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, High-Risk Cancer, Maintenance Therapy
- What is being tested?
- Maintenance Therapy with Toripalimab and Capecitabine and Maintenance Therapy with Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 3 sitesChina
- Study dates
- 7 Mar 2024to 20 Feb 2031
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed nasopharyngeal carcinoma;
- High-risk nasopharyngeal cancer meets one of three points: a. TanyN3M0; b. High-grade rENE, coalescent nodal or invasion of surrounding structures (muscle, skin, nerves, etc.); c. Detectable EBV DNA after 2 cycles of induction chemotherapy.
- 3.18-70 years old, both genders; 4. ECOG≤1; 5. Received 2-3 cycles of induction chemotherapy and concurrent chemoradiotherapy (intensity-modulated radiotherapy); 6. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L.
- 7. All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative; 8. Written informed consent;
Who cannot join
- Recurrent or distant metastatic nasopharyngeal carcinoma.
- History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
- Has received any prior radiotherapy (RT) or systemic anti-cancer therapy including investigational agents for NPC
- Has received prior therapy with an anti-PD-1 mab.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Note: Patients with the following diseases are not excluded and may proceed to further screening:
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- Controlled Type I diabetes
- Hypothyroidism (provided it is managed with hormone replacement therapy only)
- Controlled celiac disease
- Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia) Any other disease that is not expected to recur in the absence of external triggering factors.
- Any condition that required systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the start of the study。
- Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
- Adrenal replacement steroid (dose ≤10 mg daily of prednisone or equivalent)
- Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
- Short course (≤7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)。
- With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
- With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
- Severe infections within 4 weeks before the start of the study, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Received therapeutic oral or intravenous antibiotics within 2 weeks before start of the study.
- A known history of HIV infection
- Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is >1000 IU/mL or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA <1000 IU/mL), and cured hepatitis C patients can be enrolled.
- Any major surgical procedure requiring general anaesthesia ≤28 days before start of study。
- Prior allogeneic stem cell transplantation or organ transplantation.
- Any of the following cardiovascular risk factors:
- Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤28 days before start of study
- Pulmonary embolism ≤28 days before start of study
- Any history of acute myocardial infarction ≤6 months before start of study
- Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV ≤6 months before start of study
- Any event of ventricular arrhythmia ≥Grade 2 in severity ≤6 months before start of study
- Any history of cerebrovascular accident ≤6 months before start of study
- Uncontrolled hypertension: systolic pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite anti-hypertension medications ≤28 days before start of study
- Any episode of syncope or seizure ≤28 days before start of study.
- A history of severe hypersensitivity reactions to toripalimab, capecitabine and/or any of its excipients.
- Has received any herbal medicine used to control cancer within 14 days of the start of study
- Patients with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities)
- Concurrent participation in another therapeutic clinical study
- Emotional disturbance or mental illness
- Refusal or inability to sign informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, 341000
Wei Wu, M.D.
Wei Wu, M.D.
- Recruiting
First Affiliated hospital of Gannan Medical University
Guangzhou, Jiangxi, 341000
Mingjun Xu, MD
Mingjun Xu, MD
- Recruiting
Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital
Nanchang, None Selected, 330029
Tianzhu Lu, 8615270186250, lutianzhu2008@163.com
Jingao Li, PhD
About this study
Official title: Maintenance Therapy With Toripalimab Combined With Capecitabine Versus Maintenancetherapy With Capecitabine Alone in High-risk Nasopharyngeal Carcinoma: a Multicenter, Prospective, Randomized Phase III Clinical Trial (NPC-ICMB)
N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure.
The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy).
Read the detailed description
The study randomly divided these three types of high-risk nasopharyngeal carcinoma into two groups. The experimental group received maintenance therapy with toripalimab and capecitabine, while the control group received maintenance therapy with capecitabine alone. The maintenance treatment period of the two groups was 1 year.
- Being tested
- Maintenance Therapy with Toripalimab and Capecitabine, Maintenance Therapy with Capecitabine
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance Therapy with Toripalimab and CapecitabineDrug
Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. Maintenance therapy of Toripalimab (240 mg, every 3 weeks). The total treatment time of oral chemotherapy is 12 months.
Maintenance Therapy with CapecitabineDrug
Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. The total treatment time of oral chemotherapy is 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Therapy with Toripalimab and Capecitabine | Experimental | Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. Maintenance therapy of Toripalimab (240 mg, every 3 weeks). The total treatment time of oral chemotherapy is 12 months. Receives: Drug: Maintenance Therapy with Toripalimab and Capecitabine |
| Maintenance Therapy with Capecitabine alone | Active comparator | Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. The total treatment time of oral chemotherapy is 12 months. Receives: Drug: Maintenance Therapy with Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Time from date of start of treatment to disease progression or death from any cause.
Measured: 3 years
Secondary outcomes (3)
Distant Metastasis-Free Survival
Time from date of start of treatment to documented distant metastasis or death from any cause, patients with locoregional relapse as a first event will be censored at date of locoregional relapse.
Measured: 3 years
Overall Survival
Time from date of start of treatment to death from any cause, where patients lost to follow-up were censored at the date of last follow-up.
Measured: 3 years
Loco-Regional Recurrence-Free Survival
Time from date start of treatment to documented locoregional relapse or death from any cause, patients with distant metastasis as a first event will be censored at the date of distant metastasis.
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 posted26 Feb 2024
- Study start7 Mar 2024
- Primary completion20 Feb 2030 (estimated)
- Study completion20 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- 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
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingao Li, Study chair, Jiangxi Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277050
- Sponsor's protocol ID
- NPC-ICMB
- Status last verified
- May 2026
- First submitted
- 18 Feb 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapy With Toripalimab Combined With Capecitabine Versus Maintenancetherapy With Capecitabine Alone in High-risk Nasopharyngeal Carcinoma: a Multicenter, Prospective, Randomized Phase III Clinical Trial (NPC-ICMB)
- ClinicalTrials.gov ID
- NCT06277050
- Acronym / sponsor ID
- NPC-ICMB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 20 Feb 2030 (estimated)
- Study completion
- 20 Feb 2031 (estimated)
- First posted
- 26 Feb 2024 (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.
N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure.
The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy).
Detailed description
The study randomly divided these three types of high-risk nasopharyngeal carcinoma into two groups. The experimental group received maintenance therapy with toripalimab and capecitabine, while the control group received maintenance therapy with capecitabine alone. The maintenance treatment period of the two groups was 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance Therapy with Toripalimab and Capecitabine | Experimental | Drug: Maintenance Therapy with Toripalimab and CapecitabineCapecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. Maintenance therapy of Toripalimab (240 mg, every 3 weeks). The total treatment time of oral chemotherapy is 12 months. |
| Maintenance Therapy with Capecitabine alone | Active comparator | Drug: Maintenance Therapy with CapecitabineCapecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. The total treatment time of oral chemotherapy is 12 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed nasopharyngeal carcinoma;
- High-risk nasopharyngeal cancer meets one of three points: a. TanyN3M0; b. High-grade rENE, coalescent nodal or invasion of surrounding structures (muscle, skin, nerves, etc.); c. Detectable EBV DNA after 2 cycles of induction chemotherapy.
- 3.18-70 years old, both genders; 4. ECOG≤1; 5. Received 2-3 cycles of induction chemotherapy and concurrent chemoradiotherapy (intensity-modulated radiotherapy); 6. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L.
- 7. All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative; 8. Written informed consent;
Key exclusion criteria (38 listed)
- Recurrent or distant metastatic nasopharyngeal carcinoma.
- History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
- Has received any prior radiotherapy (RT) or systemic anti-cancer therapy including investigational agents for NPC
- Has received prior therapy with an anti-PD-1 mab.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
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 |
|---|---|---|
| Maintenance Therapy with Toripalimab and CapecitabineCapecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. Maintenance therapy of Toripalimab (240 mg, every 3 weeks). The total treatment time of oral chemotherapy is 12 months. | Drug | Maintenance Therapy with Toripalimab and Capecitabine |
| Maintenance Therapy with CapecitabineCapecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. The total treatment time of oral chemotherapy is 12 months. | Drug | Maintenance Therapy with Capecitabine alone |
Primary outcome
Progression-free Survival
Time frame: 3 years
Time from date of start of treatment to disease progression or death from any cause.
3 secondary outcomes
Distant Metastasis-Free Survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
Loco-Regional Recurrence-Free Survival
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 15 May 2026.
- Individual participant dataSharing planned: No
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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.
Jingao Li study chair
Jiangxi Provincial Cancer Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maintenance Therapy with Toripalimab and Capecitabine and Maintenance Therapy with Capecitabine in people with Nasopharyngeal Carcinoma and High-Risk Cancer, run by Jiangxi Provincial Cancer Hospital at 3 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 4 inclusion and 38 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 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Jingao Li, MD (86079188300252, lijingao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: 3 years). 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 15 May 2026.