Nasopharyngeal CarcinomaPhase 3NCT07540390
GAPP Induction and Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced NPC.
A Phase 3 study testing Toripalimab, Anlotinib and Cisplatin in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The investigators have designed a multicenter, open-label, randomized controlled phase III clinical study of GAPP induction therapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Toripalimab, Anlotinib and Cisplatin
- 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
- 442 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2026to 31 Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation and signed informed consent.
- Age 18-65 years, male or non-pregnant female.
- Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).
- Previously untreated patients with no history of other malignancies; initial treatment for nasopharyngeal carcinoma.
- Stage III: TanyN3M0 / T4N0-2M0 (9th AJCC/UICC staging system).
- ECOG performance status 0-1, with no severe dysfunction of vital organs (heart, lung, liver, kidney, etc.).
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- Hemoglobin (HGB) ≥90 g/L, white blood cell count (WBC) ≥4.0×10^9 /L, platelet count (PLT) ≥100×10^9/L.
- Liver function: ALT and AST <2.5× upper limit of normal (ULN); total bilirubin <2.0×ULN.
- Renal function: serum creatinine <1.5×ULN.
Who cannot join
- Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
- Pathologically confirmed keratinizing squamous cell carcinoma (WHO type I).
- Receipt of systemic or topical glucocorticoid therapy within 4 weeks prior to enrollment.
- Participation in another clinical trial of an investigational drug within 3 months prior to treatment.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Patients with idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans), radiation pneumonitis that is clinically symptomatic or requires steroid therapy, active pneumonitis, or other moderate-to-severe pulmonary diseases that significantly affect lung function.
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- Comorbidities requiring long-term immunosuppressive medication or systemic/topical corticosteroids at immunosuppressive doses.
- Prior use of anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulatory or checkpoint pathways) with documented disease progression at the time of study entry.
- Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis). Patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients requiring bronchodilators for medical management of asthma are excluded.
- HIV-positive; HBsAg-positive with detectable HBV DNA copy number (quantitative detection ≥1000 cps/mL); positive hepatitis C antibody (HCV Ab) with detectable HCV RNA.
- Receipt of any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine) within 4 weeks prior to enrollment.
- Positive pregnancy test in women of childbearing potential, or lactating women.
- Inability to comply with scheduled follow-up due to psychological, social, family, or geographical reasons.
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
Sun yat-sen university cancer center
Guangzhou, Guangdong, 510060
Yi-Jun Hua, Phd., 18820019088, huayj@sysucc.org.cn
About this study
Official title: An Open-label, Multicenter, Randomized Controlled Phase III Clinical Trial of PD-1 Monoclonal Antibody Plus Anlotinib Combined With Induction and Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma.
The investigators have designed a multicenter, open-label, randomized controlled phase III clinical study of GAPP induction therapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition). The aim is to obtain high-level, high-quality evidence-based data to clarify the efficacy and safety of combining chemoradiotherapy with PD-1 antibody and anlotinib, thereby providing a new treatment strategy to improve the prognosis of patients with high-risk locoregionally advanced nasopharyngeal carcinoma. In this study, GPP induction chemotherapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy is selected as the control group. This regimen is currently the standard treatment recommended by guidelines for high-risk locoregionally advanced nasopharyngeal carcinoma, with well-established efficacy and broad clinical application. It provides a reliable benchmark for comparing the efficacy and safety of the experimental group, meets ethical requirements, and has mature clinical operational procedures.
Read the detailed description
The investigators have designed a multicenter, open-label, randomized controlled phase III clinical study of GAPP (gemcitabine + anlotinib + cisplatin + toripalimab) induction therapy followed by concurrent chemoradiotherapy (cisplatin) and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition). The aim is to obtain high-level, high-quality evidence-based data to clarify the efficacy and safety of combining chemoradiotherapy with PD-1 antibody and anlotinib, thereby providing a new treatment strategy to improve the prognosis of patients with high-risk locoregionally advanced nasopharyngeal carcinoma. In this study, GPP (gemcitabine + cisplatin + toripalimab) induction chemotherapy followed by concurrent chemoradiotherapy (cisplatin) and toripalimab maintenance therapy is selected as the control group. This regimen is currently the standard treatment recommended by guidelines for high-risk locoregionally advanced nasopharyngeal carcinoma, with well-established efficacy and broad clinical application. It provides a reliable benchmark for comparing the efficacy and safety of the experimental group, meets ethical requirements, and has mature clinical operational procedures.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Toripalimab, Anlotinib, Cisplatin, Gemcitabine, radiation
- Keywords
- Locoregionally advanced, Stage III (AJCC 9th edition)
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Toripalimab, 240 mg per administration, on Day 1, diluted in 100 mL of normal saline, administered as an intravenous infusion over 30 minutes (no less than 20 minutes and no more than 60 minutes). After the toripalimab infusion, there should be an interval of 30-60 minutes before administering gemcitabine and cisplatin. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 9 cycles will be administered.
AnlotinibDrug
Anlotinib, 8 mg per dose per day, once daily on Days 1-14, taken orally before breakfast. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 3 cycles will be administered.
CisplatinDrug
Cisplatin, with a treatment cycle of 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 5 cycles will be administered.
GemcitabineDrug
Gemcitabine, 1000 mg/m², on Days 1 and 8, diluted in 500 mL of 0.9% normal saline, administered as an intravenous infusion. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 3 cycles will be administered.
radiationRadiation
IMRT
| Study group | Role | What they receive |
|---|---|---|
| GAPP group | Experimental | GAPP (gemcitabine + anlotinib + cisplatin + toripalimab) induction therapy followed by concurrent chemoradiotherapy (cisplatin) and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition) Receives: Drug: Toripalimab; Drug: Anlotinib; Drug: Cisplatin; Drug: Gemcitabine; Radiation: radiation |
| GPP group | Active comparator | GPP (gemcitabine + cisplatin + toripalimab) induction therapy followed by concurrent chemoradiotherapy (cisplatin) and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition) Receives: Drug: Toripalimab; Drug: Cisplatin; Drug: Gemcitabine; Radiation: radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progression-free survival
3-year progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start8 May 2026 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (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.
- 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
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiJun Hua, Sun Yat-sen University
- Investigators
- Yi-Jun Hua, Phd., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540390
- Sponsor's protocol ID
- 2025-FXY-482-NPC
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers who have been approved can share.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Randomized Controlled Phase III Clinical Trial of PD-1 Monoclonal Antibody Plus Anlotinib Combined With Induction and Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma.
- ClinicalTrials.gov ID
- NCT07540390
- Acronym / sponsor ID
- 2025-FXY-482-NPC
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Locoregionally advanced, Stage III (AJCC 9th edition)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 8 May 2026 (estimated)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 20 Apr 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 investigators have designed a multicenter, open-label, randomized controlled phase III clinical study of GAPP induction therapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition). The aim is to obtain high-level, high-quality evidence-based data to clarify the efficacy and safety of combining chemoradiotherapy with PD-1 antibody and anlotinib, thereby providing a new treatment strategy to improve the prognosis of patients with high-risk locoregionally advanced nasopharyngeal carcinoma. In this study, GPP induction chemotherapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy is selected as the control group. This regimen is currently the standard treatment recommended by guidelines for high-risk locoregionally advanced nasopharyngeal carcinoma, with well-established efficacy and broad clinical application. It provides a reliable benchmark for comparing the efficacy and safety of the experimental group, meets ethical requirements, and has mature clinical operational procedures.
Detailed description
The investigators have designed a multicenter, open-label, randomized controlled phase III clinical study of GAPP (gemcitabine + anlotinib + cisplatin + toripalimab) induction therapy followed by concurrent chemoradiotherapy (cisplatin) and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition). The aim is to obtain high-level, high-quality evidence-based data to clarify the efficacy and safety of combining chemoradiotherapy with PD-1 antibody and anlotinib, thereby providing a new treatment strategy to improve the prognosis of patients with high-risk locoregionally advanced nasopharyngeal carcinoma. In this study, GPP (gemcitabine + cisplatin + toripalimab) induction chemotherapy followed by concurrent chemoradiotherapy (cisplatin) and toripalimab maintenance therapy is selected as the control group. This regimen is currently the standard treatment recommended by guidelines for high-risk locoregionally advanced nasopharyngeal carcinoma, with well-established efficacy and broad clinical application. It provides a reliable benchmark for comparing the efficacy and safety of the experimental group, meets ethical requirements, and has mature clinical operational procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAPP group | Experimental | Drug: Toripalimab, Drug: Anlotinib, Drug: Cisplatin, Drug: Gemcitabine, Radiation: radiationGAPP (gemcitabine + anlotinib + cisplatin + toripalimab) induction therapy followed by concurrent chemoradiotherapy (cisplatin) and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition) |
| GPP group | Active comparator | Drug: Toripalimab, Drug: Cisplatin, Drug: Gemcitabine, Radiation: radiationGPP (gemcitabine + cisplatin + toripalimab) induction therapy followed by concurrent chemoradiotherapy (cisplatin) and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary participation and signed informed consent.
- Age 18-65 years, male or non-pregnant female.
- Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).
- Previously untreated patients with no history of other malignancies; initial treatment for nasopharyngeal carcinoma.
- Stage III: TanyN3M0 / T4N0-2M0 (9th AJCC/UICC staging system).
Key exclusion criteria (13 listed)
- Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
- Pathologically confirmed keratinizing squamous cell carcinoma (WHO type I).
- Receipt of systemic or topical glucocorticoid therapy within 4 weeks prior to enrollment.
- Participation in another clinical trial of an investigational drug within 3 months prior to treatment.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
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 |
|---|---|---|
| ToripalimabToripalimab, 240 mg per administration, on Day 1, diluted in 100 mL of normal saline, administered as an intravenous infusion over 30 minutes (no less than 20 minutes and no more than 60 minutes). After the toripalimab infusion, there should be an interval of 30-60 minutes before administering gemcitabine and cisplatin. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 9 cycles will be administered. | Drug | GAPP group, GPP group |
| AnlotinibAnlotinib, 8 mg per dose per day, once daily on Days 1-14, taken orally before breakfast. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 3 cycles will be administered. | Drug | GAPP group |
| CisplatinCisplatin, with a treatment cycle of 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 5 cycles will be administered. | Drug | GAPP group, GPP group |
| GemcitabineGemcitabine, 1000 mg/m², on Days 1 and 8, diluted in 500 mL of 0.9% normal saline, administered as an intravenous infusion. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 3 cycles will be administered. | Drug | GAPP group, GPP group |
| radiationIMRT | Radiation | GAPP group, GPP group |
Primary outcome
3-year progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
3-year progression-free survival
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 22 Apr 2026.
- Individual participant dataSharing planned: No. Researchers who have been approved can share.
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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.
Yi-Jun Hua, Phd. principal investigator
Sun Yat-Sen University Cancer Center
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, Anlotinib and Cisplatin in people with Nasopharyngeal Carcinoma, 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 9 inclusion and 13 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 22 Apr 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 Yi-Jun Hua, Phd. (18820019088, huayj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year progression-free survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up 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 22 Apr 2026.