Nasopharyngeal Cancinoma (NPC)Phase 2NCT07362979
Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing GP plus Toripalimab Induction chemotherapy+CCRT, TP plus Toripalimab Induction chemotherapy+CCRT and TPC plus Toripalimab Induction chemotherapy+CCRT in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 4 sites in China.
Trial summary
This phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- GP plus Toripalimab Induction chemotherapy+CCRT, TP plus Toripalimab Induction chemotherapy+CCRT and TPC plus Toripalimab Induction chemotherapy+CCRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 4 sitesChina
- Study dates
- 12 Mar 2026to 12 Mar 2031
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years, male or non-pregnant female.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant metastasis (M0).
- ECOG performance status score of 0 or 1.
- Adequate hematological function: Hemoglobin (HGB)≥90g/L, Absolute Neutrophil Count (ANC) ≥ 1.5*10^9/L, and Platele (PLT) ≥100*10^9/L.
- Adequate hepatic function: ALT and AST≤2.5*Upper Limit of Normal (ULN), total bilirubin ≤2.0*ULN, and serum albumin≥30g/L.
- Adequate renal function: Serum creatinine ≤ 1.5*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
- International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 *ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).
Who cannot join
- Patients with nasopharyngeal carcinoma presenting with recurrence or distant metastasis.
- Pathologically confirmed diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
- Prior history of radiotherapy or systemic chemotherapy.
- Women who are pregnant, lactating, or of childbearing potential not employing effective contraception.
- HIV-positive status.
- History of other malignancies (except for cured basal cell carcinoma or carcinoma in situ of the cervix).
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- Patients previously treated with immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).
- Patients with immunodeficiency diseases or a history of organ transplantation.
- Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks prior.
- Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function.
- Concurrent use of other investigational drugs or current participation in another clinical trial.
- Patients who refuse or are unable to provide signed informed consent for trial participation.
- Patients with personality or psychiatric disorders, or those lacking legal capacity or with limited legal capacity.
- Hepatitis B surface antigen (HBsAg) positive with peripheral blood Hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000 copies/ml.
- Patients with positive Hepatitis C virus (HCV) antibody test results are eligible only if the HCV ribonucleic acid (RNA) polymerase chain reaction test result is negative.
- Arterial or venous thrombotic events within 6 months prior to screening initiation, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
- Known history of active tuberculosis (TB). Subjects suspected of having active TB must be evaluated and ruled out via chest X-ray, sputum examination, and clinical signs and symptoms.
- 21.Any other severe, uncontrolled medical condition, infection, or treatment contraindication, or any other condition that, in the investigator's judgment, may pose a risk for receiving the investigational drug, or may interfere with the assessment of the investigational drug, subject safety, or interpretation of the study results.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Dongguan People's Hospital
Dongguan, Guangdong
Zhi-Gang Liu, Dr., +8613712645531, zhigangliu1983@hotmail.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Hai-Qiang Mai, Dr., +8602087343380, maihq@sysucc.org.cn
Li-Ting Liu, Dr., +8602087343380, liult@sysucc.org.cn
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong
Jiang-Hu Zhang, Dr., +8618601399559, 18601399559@163.com
- Recruiting
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
Hai-Qing Luo, Dr., +8613729196345, hqluo@126.com
About this study
Official title: Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma: A Randomized, Open-label, Controlled, Multicenter Phase II Trial
This phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). The study is aimed to pick up the most effective platinum-based induction chemotherapy regimen plus Toripalimab for these patients which provides the most survival benefit.
Read the detailed description
This phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). The enrolled patients will be 1:1:1 randomly assigned to receive induction chemotherapy of Gemcitabine plus Cisplatin plus Toripalimab(GP plus Toripalimab regimen), Nab-paclitaxel plus Cisplatin plus Toripalimab (TP plus Toripalimab regimen) or Nab-paclitaxel plus Cisplatin plus Capecitabine plus Toripalimab(TPC plus Toripalimab regimen).The study is aimed to pick up the most effective platinum-based induction chemotherapy regimen plus Toripalimab for these patients which provides the most survival benefit.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- GP plus Toripalimab Induction chemotherapy+CCRT, TP plus Toripalimab Induction chemotherapy+CCRT, TPC plus Toripalimab Induction chemotherapy+CCRT
- Keywords
- nasopharyngeal carcinoma, Toripalimab, different platinum-based induction chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP plus Toripalimab Induction chemotherapy+CCRTDrug
Induction Chemotherapy + Immunotherapy (3 Cycles):
Gemcitabine 1000mg/m^2 (Days 1, 8) + Cisplatin 80mg/m^2 (Day 1) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Sequentially followed by Concurrent Chemoradiotherapy (CCRT): Cisplatin 100mg/m^2 (Day 1), administered every 3 weeks for a total of 3 cycles during the radiotherapy period (on Days 1, 22, and 43 of radiotherapy).
TP plus Toripalimab Induction chemotherapy+CCRTDrug
Induction Chemotherapy + Immunotherapy (3 Cycles):
Nab-paclitaxel 260mg/m^2 (Days 1) + Cisplatin 75mg/m^2 (Day 1) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Sequentially followed by Concurrent Chemoradiotherapy (CCRT): Cisplatin 100mg/m^2 (Day 1), administered every 3 weeks for a total of 3 cycles during the radiotherapy period (on Days 1, 22, and 43 of radiotherapy).
TPC plus Toripalimab Induction chemotherapy+CCRTDrug
Induction Chemotherapy + Immunotherapy (3 Cycles):
Nab-paclitaxel 200mg/m^2 (Days 1) + Cisplatin 75mg/m^2 (Day 1) + Capecitabine 1000mg/m^2 BID (Day 1-Day14) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Sequentially followed by Concurrent Chemoradiotherapy (CCRT): Cisplatin 100mg/m^2 (Day 1), administered every 3 weeks for a total of 3 cycles during the radiotherapy period (on Days 1, 22, and 43 of radiotherapy).
| Study group | Role | What they receive |
|---|---|---|
| GP plus Toripalimab Induction chemotherapy | Experimental | Induction Chemotherapy + Immunotherapy (3 Cycles): Gemcitabine 1000mg/m^2 (Days 1, 8) + Cisplatin 80mg/m^2 (Day 1) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Receives: Drug: GP plus Toripalimab Induction chemotherapy+CCRT |
| TP plus Toripalimab Induction chemotherapy | Experimental | Induction Chemotherapy + Immunotherapy (3 Cycles): Nab-paclitaxel 260mg/m^2 (Days 1) + Cisplatin 75mg/m^2 (Day 1) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Receives: Drug: TP plus Toripalimab Induction chemotherapy+CCRT |
| TPC plus Toripalimab Induction chemotherapy | Experimental | Induction Chemotherapy + Immunotherapy (3 Cycles): Nab-paclitaxel 200mg/m^2 (Days 1) + Cisplatin 75mg/m^2 (Day 1) + Capecitabine 1000mg/m^2 BID (Day 1-Day14) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Receives: Drug: TPC plus Toripalimab Induction chemotherapy+CCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The time from randomization to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occur first.
Measured: 2 years
Secondary outcomes (5)
Overall survival
The time from randomization to death from any cause or censored at the date of the last follow-up.
Measured: 2 years
Local-Regional failure free survial
The time from randomization to documented local and/or regional recurrence, or death from any cause.
Measured: 2 years
Distant metastasis-free survival
The time from randomization to distant metastasis or death from any cause.
Measured: 2 years
Complete Response Rate
CR is assessed by independent reviewers after induction chemotherapy, according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST v1.1). Complete response is defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) .
Complete response rate is defined as the percentage of evaluable patients achieving Complete Response following induction chemotherapy.
Measured: 9 weeks
Incidence of Acute and Late Toxicity
Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start12 Mar 2026
- Primary completion12 Mar 2029 (estimated)
- Study completion12 Mar 2031 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362979
- Sponsor's protocol ID
- 2025-FXY-446
- Status last verified
- Mar 2026
- First submitted
- 15 Jan 2026
- Last updated
- 17 Mar 2026
- Results posted
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma: A Randomized, Open-label, Controlled, Multicenter Phase II Trial
- ClinicalTrials.gov ID
- NCT07362979
- Acronym / sponsor ID
- 2025-FXY-446
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Keywords
- nasopharyngeal carcinoma, Toripalimab, different platinum-based induction chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 243 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 12 Mar 2029 (estimated)
- Study completion
- 12 Mar 2031 (estimated)
- First posted
- 23 Jan 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 phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). The study is aimed to pick up the most effective platinum-based induction chemotherapy regimen plus Toripalimab for these patients which provides the most survival benefit.
Detailed description
This phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). The enrolled patients will be 1:1:1 randomly assigned to receive induction chemotherapy of Gemcitabine plus Cisplatin plus Toripalimab(GP plus Toripalimab regimen), Nab-paclitaxel plus Cisplatin plus Toripalimab (TP plus Toripalimab regimen) or Nab-paclitaxel plus Cisplatin plus Capecitabine plus Toripalimab(TPC plus Toripalimab regimen).The study is aimed to pick up the most effective platinum-based induction chemotherapy regimen plus Toripalimab for these patients which provides the most survival benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GP plus Toripalimab Induction chemotherapy | Experimental | Drug: GP plus Toripalimab Induction chemotherapy+CCRTInduction Chemotherapy + Immunotherapy (3 Cycles): Gemcitabine 1000mg/m^2 (Days 1, 8) + Cisplatin 80mg/m^2 (Day 1) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. |
| TP plus Toripalimab Induction chemotherapy | Experimental | Drug: TP plus Toripalimab Induction chemotherapy+CCRTInduction Chemotherapy + Immunotherapy (3 Cycles): Nab-paclitaxel 260mg/m^2 (Days 1) + Cisplatin 75mg/m^2 (Day 1) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. |
| TPC plus Toripalimab Induction chemotherapy | Experimental | Drug: TPC plus Toripalimab Induction chemotherapy+CCRTInduction Chemotherapy + Immunotherapy (3 Cycles): Nab-paclitaxel 200mg/m^2 (Days 1) + Cisplatin 75mg/m^2 (Day 1) + Capecitabine 1000mg/m^2 BID (Day 1-Day14) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 70 years, male or non-pregnant female.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant metastasis (M0).
- ECOG performance status score of 0 or 1.
- Adequate hematological function: Hemoglobin (HGB)≥90g/L, Absolute Neutrophil Count (ANC) ≥ 1.5*10^9/L, and Platele (PLT) ≥100*10^9/L.
Key exclusion criteria (18 listed)
- Patients with nasopharyngeal carcinoma presenting with recurrence or distant metastasis.
- Pathologically confirmed diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
- Prior history of radiotherapy or systemic chemotherapy.
- Women who are pregnant, lactating, or of childbearing potential not employing effective contraception.
- HIV-positive status.
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 |
|---|---|---|
| GP plus Toripalimab Induction chemotherapy+CCRTInduction Chemotherapy + Immunotherapy (3 Cycles): Gemcitabine 1000mg/m^2 (Days 1, 8) + Cisplatin 80mg/m^2 (Day 1) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Sequentially followed by Concurrent Chemoradiotherapy (CCRT): Cisplatin 100mg/m^2 (Day 1), administered every 3 weeks for a total of 3 cycles during the radiotherapy period (on Days 1, 22, and 43 of radiotherapy). | Drug | GP plus Toripalimab Induction chemotherapy |
| TP plus Toripalimab Induction chemotherapy+CCRTInduction Chemotherapy + Immunotherapy (3 Cycles): Nab-paclitaxel 260mg/m^2 (Days 1) + Cisplatin 75mg/m^2 (Day 1) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Sequentially followed by Concurrent Chemoradiotherapy (CCRT): Cisplatin 100mg/m^2 (Day 1), administered every 3 weeks for a total of 3 cycles during the radiotherapy period (on Days 1, 22, and 43 of radiotherapy). | Drug | TP plus Toripalimab Induction chemotherapy |
| TPC plus Toripalimab Induction chemotherapy+CCRTInduction Chemotherapy + Immunotherapy (3 Cycles): Nab-paclitaxel 200mg/m^2 (Days 1) + Cisplatin 75mg/m^2 (Day 1) + Capecitabine 1000mg/m^2 BID (Day 1-Day14) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Sequentially followed by Concurrent Chemoradiotherapy (CCRT): Cisplatin 100mg/m^2 (Day 1), administered every 3 weeks for a total of 3 cycles during the radiotherapy period (on Days 1, 22, and 43 of radiotherapy). | Drug | TPC plus Toripalimab Induction chemotherapy |
Primary outcome
Progression-free survival
Time frame: 2 years
The time from randomization to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occur first.
5 secondary outcomes
Overall survival
Time frame: 2 years
Local-Regional failure free survial
Time frame: 2 years
Distant metastasis-free survival
Time frame: 2 years
Complete Response Rate
Time frame: 9 weeks
Incidence of Acute and Late Toxicity
Time frame: 2 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 17 Mar 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GP plus Toripalimab Induction chemotherapy+CCRT, TP plus Toripalimab Induction chemotherapy+CCRT and TPC plus Toripalimab Induction chemotherapy+CCRT in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 4 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 8 inclusion and 18 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 Hai-Qiang Mai, Dr. (+8602087343380, maihq@sysucc.org.cn), 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: 2 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 17 Mar 2026.