Nasopharyngeal Carcinoma (NPC)Phase 3NCT07706985
Efficacy and Safety of TPC Induction Chemotherapy Combined With Nimotuzumab and Toripalimab "Immune Sandwich" Regimen Versus Full-Course Immunotherapy for Locally Advanced Nasopharyngeal Carcinoma
A Phase 3 study testing Toripalimab combined with Nimotuzumab and Nimotuzumab in people with Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University at 1 site in China.
Trial summary
Immunotherapy combined with chemoradiotherapy has become standard care for locally advanced nasopharyngeal carcinoma, yet radiotherapy-induced lymphopenia may impair the efficacy of concurrent PD-1 blockade. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Toripalimab combined with Nimotuzumab and Nimotuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 20 Jul 2033
- 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
- Aged between 18 and 70 years, regardless of gender
- Histologically or cytologically confirmed diagnosis of nasopharyngeal carcinoma
- Locoregionally advanced nasopharyngeal carcinoma classified as Stage III-IVA per the 8th AJCC staging system, excluding T3-4N0 and T3N1 disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ and bone marrow function as demonstrated by laboratory test results obtained within 7 days prior to enrollment. No blood products, hematopoietic growth factors, albumin, or other intravenous/subcutaneous corrective medications are permitted within 14 days before laboratory testing. Specific criteria are listed below.Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet (PLT) count ≥ 75 × 10⁹/L; Hemoglobin (HGB) ≥ 9.0 g/dL;Liver function: Total Bilirubin (TBIL) ≤ 2 × Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 5 × ULN; serum albumin ≥ 28 g/L; Alkaline Phosphatase (ALP) ≤ 5 × ULN. Renal function: Serum Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance (CCr) ≥ 50 mL/min (calculated via the Cockcroft-Gault formula). For patients with urine protein ≥ 2+ on routine urinalysis, a 24-hour urine collection is required, with total 24-hour urinary protein quantification < 1 g. Coagulation function: International Normalized Ratio (INR) ≤ 2.3, or prothrombin time (PT) prolongation ≤ 6 seconds
- Able to provide written informed consent and comply with all protocol-specified study visits and related procedures.
Who cannot join
- Diagnosis of another malignant tumor within 5 years prior to the first study drug administration, excluding radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ
- Symptomatic congestive heart failure (New York Heart Association [NYHA] Class II-IV) or left ventricular ejection fraction (LVEF) <50% on echocardiography
- Patients with acute or chronically active hepatitis B or hepatitis C infection: HBV DNA >2000 IU/mL or 10⁴ copies/mL; HCV RNA >10³ copies/mL; concurrent positive hepatitis B surface antigen (HBsAg) and anti-HCV antibody. Subjects with viral loads below the above thresholds after nucleotide antiviral therapy are eligible for enrollment
- Past or current history of pulmonary diseases including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonitis, or severely impaired pulmonary function
- Active tuberculosis (TB) receiving anti-tuberculosis treatment, or having received anti-tuberculosis therapy within 1 year before the first study drug dose.
- Human immunodeficiency virus (HIV) infection (positive HIV 1/2 antibody), or known syphilis infection requiring treatment
Show all 11Show fewer
- Severe active or poorly controlled infections. Severe infection requiring hospitalization within 4 weeks before the first dose, including but not limited to complications from infection, bacteremia, or severe pneumonia
- History of active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, physiological corticosteroids for adrenal or pituitary insufficiency) are permitted. Known history of primary immunodeficiency. Subjects with only positive autoantibodies will be assessed by the investigator to confirm the presence of autoimmune disease
- Female patients who are pregnant or breastfeeding
- Prior radiotherapy, chemotherapy, or surgery for nasopharyngeal and cervical lesions (excluding biopsy)
- History of hypersensitivity to any study drug or its components
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Liu Guoying, 18127919832, liugy0109@163.com
About this study
Official title: Efficacy and Safety of TPC Induction Chemotherapy Combined With Nimotuzumab and Toripalimab "Immune Sandwich" Regimen Versus Full-Course Immunotherapy for Locally Advanced Nasopharyngeal Carcinoma: A Multicenter, Randomized, Open-Label, Non-Inferiority Phase III Clinical Study
Immunotherapy combined with chemoradiotherapy has become standard care for locally advanced nasopharyngeal carcinoma, yet radiotherapy-induced lymphopenia may impair the efficacy of concurrent PD-1 blockade. Existing evidence supports synergistic anti-tumor activity between the anti-EGFR antibody nimotuzumab and toripalimab. This multicenter, open-label, non-inferiority Phase III trial randomizes eligible stage III-IVA LA-NPC patients 1:1 to two arms. The experimental group receives an "immune sandwich" regimen: TPC induction plus nimotuzumab and toripalimab, concurrent radiotherapy with weekly nimotuzumab only, followed by toripalimab maintenance. The control arm adopts full-course toripalimab throughout induction, concurrent radiotherapy and adjuvant phases. The primary endpoint is 3-year event-free survival, with secondary endpoints covering overall survival, local/distant control rates, objective response rate and treatment-related toxicities. A total of 566 subjects will be enrolled to verify whether the simplified sandwich strategy delivers non-inferior survival with better safety profiles.
Read the detailed description
The survival outcomes of patients with locally advanced nasopharyngeal carcinoma (LA-NPC) have been greatly elevated with the combination of immunotherapy and targeted therapy. Numerous previous studies have confirmed that PD-1 immune checkpoint inhibitors exert prominent anti-tumor efficacy for locally advanced nasopharyngeal carcinoma. Large-scale Phase III trials including CONTINUUM, DIPPER and DIAMOND verified that adding anti-PD-1 agents to chemoradiotherapy remarkably extended event-free survival (EFS) of high-risk LA-NPC patients, with the 3-year EFS rate reaching up to 86%-88%. In addition, anti-EGFR targeted antibody nimotuzumab could boost radiotherapy sensitivity and further optimize long-term survival for LA-NPC patients when combined with comprehensive chemoradiotherapy. Mechanistic research revealed that EGFR pathway activation upregulates tumor PD-L1 expression, and the combination of nimotuzumab and toripalimab generates synergistic anti-tumor effects.
However, intensive full-course immunotherapy throughout induction, concurrent and adjuvant phases may lead to severe treatment-related lymphopenia during radiotherapy, which potentially weakens immunotherapeutic efficacy and increases adverse reaction risks. Our previous exploratory trial demonstrated an "immune sandwich" strategy (toripalimab only applied in induction and adjuvant stages without concurrent immunotherapy plus weekly nimotuzumab during radiation) achieved comparable survival benefits while reducing treatment toxicity.
This study aims to design a multicenter, randomized, open-label non-inferiority Phase III clinical trial to compare the efficacy and safety of the "immune sandwich" regimen (TPC induction chemotherapy plus nimotuzumab and toripalimab, concurrent nimotuzumab monotherapy radiotherapy followed by toripalimab maintenance) versus the full-course toripalimab combined regimen for patients with locally advanced nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Toripalimab combined with Nimotuzumab, Nimotuzumab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab combined with NimotuzumabDrug
Induction Chemotherapy Phase： TPC chemotherapy regimen: Nab-paclitaxel: 200 mg/m², intravenous infusion on Day 1；Cisplatin: 60 mg/m², intravenous infusion on Day 1；Capecitabine: 1000 mg/m² orally twice daily on Days 1-14；Each cycle lasts 21 days, for a total of 3 cycles.
Toripalimab: 240 mg toripalimab injection, intravenous infusion on Day 0; 21-day cycles for 3 cycles total.
Nimotuzumab: 400 mg nimotuzumab, intravenous infusion on Days 0 and 8; 21-day cycles for 3 cycles total.
Concurrent Radiotherapy Phase： Toripalimab: 240 mg toripalimab injection via intravenous infusion starting on the first day of radiotherapy, administered every 21 days for 3 cycles.
Nimotuzumab: 200 mg nimotuzumab via intravenous infusion once weekly for 6 consecutive weeks, starting on the first day of radiotherapy.
Adjuvant Phase： Toripalimab injection 240 mg is administered via intravenous infusion once every 21 days per cycle.
NimotuzumabDrug
Induction Chemotherapy Phase： TPC chemotherapy regimen: Nab-paclitaxel: 200 mg/m², intravenous infusion on Day 1；Cisplatin: 60 mg/m², intravenous infusion on Day 1；Capecitabine: 1000 mg/m² orally twice daily on Days 1-14；Each cycle lasts 21 days, for a total of 3 cycles.
Toripalimab: 240 mg toripalimab injection, intravenous infusion on Day 0; 21-day cycles for 3 cycles total.
Nimotuzumab: 400 mg nimotuzumab, intravenous infusion on Days 0 and 8; 21-day cycles for 3 cycles total.
Concurrent Radiotherapy Phase： Nimotuzumab: 200 mg nimotuzumab via intravenous infusion once weekly for 6 consecutive weeks, starting on the first day of radiotherapy.
Adjuvant Phase： Toripalimab injection 240 mg is administered via intravenous infusion once every 21 days per cycle.
| Study group | Role | What they receive |
|---|---|---|
| Full-Course Immunotherapy Group | Active comparator | Induction Chemotherapy Phase：TPC chemotherapy+ Toripalimab + Nimotuzumab； Concurrent Radiotherapy Phase：Nimotuzumab + Toripalimab； Adjuvant Treatment Phase：Toripalimab Receives: Drug: Toripalimab combined with Nimotuzumab |
| Concurrent Immunotherapy-Omitted Group | Experimental | Induction Chemotherapy Phase：TPC chemotherapy+ Toripalimab + Nimotuzumab； Concurrent Radiotherapy Phase：Nimotuzumab； Adjuvant Treatment Phase：Toripalimab Receives: Drug: Nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival
Defined as the time from the date of randomization to the first documented tumor progression (assessed per RECIST Version 1.1, regardless of continued study treatment) or death from any cause, whichever occurs first.
Measured: From randomization to 3 years
Secondary outcomes (5)
Overall Survival
Defined as the time from randomization to death from any cause.
Measured: From randomization to 3 years and 5 years
Locoregional Recurrence-Free Survival
Defined as the time from randomization to the first documented locoregional tumor recurrence.
Measured: From randomization to 3 years
Distant Metastasis-Free Survival
Defined as the time from randomization to the first documentation of distant tumor metastasis.
Measured: From randomization to 3 years
Objective Response Rate
The proportion of subjects achieving complete response (CR) or partial response (PR) assessed per RECIST Version 1.1 at the completion of radiotherapy in the analysis population.
Measured: 9 weeks and 3 months
Incidence of Treatment-Emergent Adverse Events
Acute toxicities will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0). Late radiation toxicities will be assessed via the Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema.
Measured: Through treatment completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion20 Jul 2030 (estimated)
- Study completion20 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (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
- 566 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIANG YANQUN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706985
- Sponsor's protocol ID
- SYSKY-2026-425-02
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 16 Jul 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of TPC Induction Chemotherapy Combined With Nimotuzumab and Toripalimab "Immune Sandwich" Regimen Versus Full-Course Immunotherapy for Locally Advanced Nasopharyngeal Carcinoma: A Multicenter, Randomized, Open-Label, Non-Inferiority Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT07706985
- Acronym / sponsor ID
- SYSKY-2026-425-02
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 566 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 20 Jul 2030 (estimated)
- Study completion
- 20 Jul 2033 (estimated)
- First posted
- 16 Jul 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.
Immunotherapy combined with chemoradiotherapy has become standard care for locally advanced nasopharyngeal carcinoma, yet radiotherapy-induced lymphopenia may impair the efficacy of concurrent PD-1 blockade. Existing evidence supports synergistic anti-tumor activity between the anti-EGFR antibody nimotuzumab and toripalimab. This multicenter, open-label, non-inferiority Phase III trial randomizes eligible stage III-IVA LA-NPC patients 1:1 to two arms. The experimental group receives an "immune sandwich" regimen: TPC induction plus nimotuzumab and toripalimab, concurrent radiotherapy with weekly nimotuzumab only, followed by toripalimab maintenance. The control arm adopts full-course toripalimab throughout induction, concurrent radiotherapy and adjuvant phases. The primary endpoint is 3-year event-free survival, with secondary endpoints covering overall survival, local/distant control rates, objective response rate and treatment-related toxicities. A total of 566 subjects will be enrolled to verify whether the simplified sandwich strategy delivers non-inferior survival with better safety profiles.
Detailed description
The survival outcomes of patients with locally advanced nasopharyngeal carcinoma (LA-NPC) have been greatly elevated with the combination of immunotherapy and targeted therapy. Numerous previous studies have confirmed that PD-1 immune checkpoint inhibitors exert prominent anti-tumor efficacy for locally advanced nasopharyngeal carcinoma. Large-scale Phase III trials including CONTINUUM, DIPPER and DIAMOND verified that adding anti-PD-1 agents to chemoradiotherapy remarkably extended event-free survival (EFS) of high-risk LA-NPC patients, with the 3-year EFS rate reaching up to 86%-88%. In addition, anti-EGFR targeted antibody nimotuzumab could boost radiotherapy sensitivity and further optimize long-term survival for LA-NPC patients when combined with comprehensive chemoradiotherapy. Mechanistic research revealed that EGFR pathway activation upregulates tumor PD-L1 expression, and the combination of nimotuzumab and toripalimab generates synergistic anti-tumor effects.
However, intensive full-course immunotherapy throughout induction, concurrent and adjuvant phases may lead to severe treatment-related lymphopenia during radiotherapy, which potentially weakens immunotherapeutic efficacy and increases adverse reaction risks. Our previous exploratory trial demonstrated an "immune sandwich" strategy (toripalimab only applied in induction and adjuvant stages without concurrent immunotherapy plus weekly nimotuzumab during radiation) achieved comparable survival benefits while reducing treatment toxicity.
This study aims to design a multicenter, randomized, open-label non-inferiority Phase III clinical trial to compare the efficacy and safety of the "immune sandwich" regimen (TPC induction chemotherapy plus nimotuzumab and toripalimab, concurrent nimotuzumab monotherapy radiotherapy followed by toripalimab maintenance) versus the full-course toripalimab combined regimen for patients with locally advanced nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-Course Immunotherapy Group | Active comparator | Drug: Toripalimab combined with NimotuzumabInduction Chemotherapy Phase：TPC chemotherapy+ Toripalimab + Nimotuzumab； Concurrent Radiotherapy Phase：Nimotuzumab + Toripalimab； Adjuvant Treatment Phase：Toripalimab |
| Concurrent Immunotherapy-Omitted Group | Experimental | Drug: NimotuzumabInduction Chemotherapy Phase：TPC chemotherapy+ Toripalimab + Nimotuzumab； Concurrent Radiotherapy Phase：Nimotuzumab； Adjuvant Treatment Phase：Toripalimab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 70 years, regardless of gender
- Histologically or cytologically confirmed diagnosis of nasopharyngeal carcinoma
- Locoregionally advanced nasopharyngeal carcinoma classified as Stage III-IVA per the 8th AJCC staging system, excluding T3-4N0 and T3N1 disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ and bone marrow function as demonstrated by laboratory test results obtained within 7 days prior to enrollment. No blood products, hematopoietic growth factors, albumin, or other intravenous/subcutaneous corrective medications are permitted within 14 days before laboratory testing. Specific criteria are listed below.Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet (PLT) count ≥ 75 × 10⁹/L; Hemoglobin (HGB) ≥ 9.0 g/dL;Liver function: Total Bilirubin (TBIL) ≤ 2 × Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 5 × ULN; serum albumin ≥ 28 g/L; Alkaline Phosphatase (ALP) ≤ 5 × ULN. Renal function: Serum Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance (CCr) ≥ 50 mL/min (calculated via the Cockcroft-Gault formula). For patients with urine protein ≥ 2+ on routine urinalysis, a 24-hour urine collection is required, with total 24-hour urinary protein quantification < 1 g. Coagulation function: International Normalized Ratio (INR) ≤ 2.3, or prothrombin time (PT) prolongation ≤ 6 seconds
Key exclusion criteria (11 listed)
- Diagnosis of another malignant tumor within 5 years prior to the first study drug administration, excluding radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ
- Symptomatic congestive heart failure (New York Heart Association [NYHA] Class II-IV) or left ventricular ejection fraction (LVEF) <50% on echocardiography
- Patients with acute or chronically active hepatitis B or hepatitis C infection: HBV DNA >2000 IU/mL or 10⁴ copies/mL; HCV RNA >10³ copies/mL; concurrent positive hepatitis B surface antigen (HBsAg) and anti-HCV antibody. Subjects with viral loads below the above thresholds after nucleotide antiviral therapy are eligible for enrollment
- Past or current history of pulmonary diseases including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonitis, or severely impaired pulmonary function
- Active tuberculosis (TB) receiving anti-tuberculosis treatment, or having received anti-tuberculosis therapy within 1 year before the first study drug dose.
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 |
|---|---|---|
| Toripalimab combined with NimotuzumabInduction Chemotherapy Phase： TPC chemotherapy regimen: Nab-paclitaxel: 200 mg/m², intravenous infusion on Day 1；Cisplatin: 60 mg/m², intravenous infusion on Day 1；Capecitabine: 1000 mg/m² orally twice daily on Days 1-14；Each cycle lasts 21 days, for a total of 3 cycles. Toripalimab: 240 mg toripalimab injection, intravenous infusion on Day 0; 21-day cycles for 3 cycles total. Nimotuzumab: 400 mg nimotuzumab, intravenous infusion on Days 0 and 8; 21-day cycles for 3 cycles total. Concurrent Radiotherapy Phase： Toripalimab: 240 mg toripalimab injection via intravenous infusion starting on the first day of radiotherapy, administered every 21 days for 3 cycles. Nimotuzumab: 200 mg nimotuzumab via intravenous infusion once weekly for 6 consecutive weeks, starting on the first day of radiotherapy. Adjuvant Phase： Toripalimab injection 240 mg is administered via intravenous infusion once every 21 days per cycle. | Drug | Full-Course Immunotherapy Group |
| NimotuzumabInduction Chemotherapy Phase： TPC chemotherapy regimen: Nab-paclitaxel: 200 mg/m², intravenous infusion on Day 1；Cisplatin: 60 mg/m², intravenous infusion on Day 1；Capecitabine: 1000 mg/m² orally twice daily on Days 1-14；Each cycle lasts 21 days, for a total of 3 cycles. Toripalimab: 240 mg toripalimab injection, intravenous infusion on Day 0; 21-day cycles for 3 cycles total. Nimotuzumab: 400 mg nimotuzumab, intravenous infusion on Days 0 and 8; 21-day cycles for 3 cycles total. Concurrent Radiotherapy Phase： Nimotuzumab: 200 mg nimotuzumab via intravenous infusion once weekly for 6 consecutive weeks, starting on the first day of radiotherapy. Adjuvant Phase： Toripalimab injection 240 mg is administered via intravenous infusion once every 21 days per cycle. | Drug | Concurrent Immunotherapy-Omitted Group |
Primary outcome
Event-Free Survival
Time frame: From randomization to 3 years
Defined as the time from the date of randomization to the first documented tumor progression (assessed per RECIST Version 1.1, regardless of continued study treatment) or death from any cause, whichever occurs first.
5 secondary outcomes
Overall Survival
Time frame: From randomization to 3 years and 5 years
Locoregional Recurrence-Free Survival
Time frame: From randomization to 3 years
Distant Metastasis-Free Survival
Time frame: From randomization to 3 years
Objective Response Rate
Time frame: 9 weeks and 3 months
Incidence of Treatment-Emergent Adverse Events
Time frame: Through treatment completion, an average of 1 year
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 16 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toripalimab combined with Nimotuzumab and Nimotuzumab in people with Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University at 1 site 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 6 inclusion and 11 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Liu Guoying (18127919832, liugy0109@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (time frame: From randomization to 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 16 Jul 2026.