Nasopharyngeal CarcinomaPhase 2NCT06851247
GAPP Induction and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance for Nasopharyngeal Carcinoma.
A Phase 2 study testing Toripalimab, Anlotinib and Gemcitabine in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
In order to explore the efficacy and safety of targeted therapy and immunotherapy combined with GP chemotherapy in the treatment of high risk advanced nasopharyngeal carcinoma, the investigators design a single-arm, Phase II clinical trial targeted high-risk patients with local stage nasopharyngeal carcinoma (stage… 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 Gemcitabine
- 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
- 47 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in and sign informed consent in person.
- Age 18-65, male or non-pregnant female.
- Pathological diagnosis of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, i.e., WHO type II or III).
- First treatment patients who did not receive antitumor therapy had no history of other malignant tumors;
- Stage IVa: TanyN3M0/T4N0-2M0 (8th AJCC/UICC stage)
- ECOG score 0-1, no serious dysfunction of heart, lung, liver, kidney and other vital organs.
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- Hemoglobin (HGB) ≥90 g/L, white blood cells (WBC) ≥4.0×109 /L, platelets (PLT) ≥100×109 /L.
- Liver function: ALT and AST< 2.5 times the upper limit of normal (ULN), total bilirubin <2.0×ULN.
- Renal function: serum creatinine <1.5×ULN.
Who cannot join
- Patients with recurrent and distant metastasis of nasopharyngeal carcinoma.
- The pathology was keratinized squamous cell carcinoma (WHO type I).
- Received systemic or local glucocorticoid therapy within 4 weeks prior to enrollment.
- Participants who had participated in other drug clinical trials within 3 months before treatment.
- Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Patients with idiopathic pulmonary fibrosis, drug-induced pneumonia, institutional pneumonia (i.e., bronchiolitis obliterans), radiation pneumonia with clinical symptoms or requiring steroid treatment, active pneumonia, or other moderate to severe lung diseases that seriously affect lung function
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- Have a comorbiditis that requires long-term treatment with immunosuppressive drugs or systemic or local use of immunosuppressive doses of corticosteroids.
- Prior use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibody that acts on the T-cell co-stimulation or checkpoint pathway), and efficacy was assessed as progressive at enrollment.
- The subject has any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; Patients with vitiligo or who had complete remission of asthma in childhood and did not require any intervention as adults were included; Patients with asthma requiring medical intervention with bronchodilators were not included).
- Positive HBV DNA copy number was detected in HIV-positive patients and HBsAg positive patients (quantitative detection ≥ 1000cps/ml); Chronic hepatitis C blood screening positive (HCV antibody positive) with HCV RNA positive detection.
- Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment.
- Pregnancy test positive women of childbearing age and breastfeeding women.
- Patients who are unable to cooperate with regular follow-up due to psychological, social, family and 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, 1 recruiting
- Recruiting
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Hua-Yi Jun, Phd, 18820019088, huayj@sysucc.org.cn
About this study
Official title: Toripalimab Plus Anlotinib Combined with GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for High-risk, Locally Advanced Nasopharyngeal Carcinoma：A Single-arm, Phase II Clinical Trial
In order to explore the efficacy and safety of targeted therapy and immunotherapy combined with GP chemotherapy in the treatment of high risk advanced nasopharyngeal carcinoma, the investigators design a single-arm, Phase II clinical trial targeted high-risk patients with local stage nasopharyngeal carcinoma (stage IVa: TanyN3M0/T4N0-2M0,8th AJCC/UICC staging) for Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy.
Read the detailed description
In order to explore the efficacy and safety of targeted therapy and immunotherapy combined with GP chemotherapy in the treatment of high risk advanced nasopharyngeal carcinoma, the investigators design a single-arm, Phase II clinical trial targeted high-risk patients with local stage nasopharyngeal carcinoma (stage IVa: TanyN3M0/T4N0-2M0,8th AJCC/UICC staging) for Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy. The investigators focus on the 2-year PFS as the primary outcome.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Toripalimab, Anlotinib, Gemcitabine, Cisplatin, radiation
- 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
Fixed dose: 240mg/ time, add 100ml normal saline, intravenous infusion for 30 minutes (not less than 20 minutes, not more than 60 minutes).
The first course of induction chemotherapy (D1) is used on the first day of each cycle, and every 21 days is a course of treatment up to 18 courses or one year.
After intravenous infusion of triplelizumab, GP regimen induction chemotherapy was administered at an interval of 30-60 minutes.
AnlotinibDrug
Oral administration before breakfast, 10mg/ time/day, once a day (d1-14), repeated every 3 weeks, using three courses, one week before radiotherapy discontinuation.
Use on the day the first course of induction chemotherapy begins (D1).
GemcitabineDrug
1000mg/m2, D1, D8, add 0.9% normal saline 500ml, intravenous infusion. Every 21 days is a treatment cycle. If the recovery of toxicity in the subject is not sufficient for the next course of chemotherapy, the start of the next course of chemotherapy may be appropriately delayed, but the delay cannot exceed 21 days.
The treatment was continued for 3 courses.
CisplatinDrug
Induction Chemotherapy: 80mg/m2, D1, add 1000ml 0.9% normal saline, intravenous infusion for 3 hours.
Concurrent Chemoradiotherapy100mg/m2, add 5% glucose 500ml, intravenous drip. Use on the first day of each cycle, every 21 days for a treatment cycle
radiationRadiation
IMRT, 33Fx
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy Receives: Drug: Toripalimab; Drug: Anlotinib; Drug: Gemcitabine; Drug: Cisplatin; Radiation: radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival
2-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 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start3 Jan 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851247
- Sponsor's protocol ID
- 2024-FXY-171-NPC
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers who has been approved can share
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Plus Anlotinib Combined with GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for High-risk, Locally Advanced Nasopharyngeal Carcinoma：A Single-arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06851247
- Acronym / sponsor ID
- 2024-FXY-171-NPC
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Feb 2025 (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.
In order to explore the efficacy and safety of targeted therapy and immunotherapy combined with GP chemotherapy in the treatment of high risk advanced nasopharyngeal carcinoma, the investigators design a single-arm, Phase II clinical trial targeted high-risk patients with local stage nasopharyngeal carcinoma (stage IVa: TanyN3M0/T4N0-2M0,8th AJCC/UICC staging) for Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy.
Detailed description
In order to explore the efficacy and safety of targeted therapy and immunotherapy combined with GP chemotherapy in the treatment of high risk advanced nasopharyngeal carcinoma, the investigators design a single-arm, Phase II clinical trial targeted high-risk patients with local stage nasopharyngeal carcinoma (stage IVa: TanyN3M0/T4N0-2M0,8th AJCC/UICC staging) for Toripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy. The investigators focus on the 2-year PFS as the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Toripalimab, Drug: Anlotinib, Drug: Gemcitabine, Drug: Cisplatin, Radiation: radiationToripalimab Plus Anlotinib Combined With GP Induction Chemotherapy and Concurrent Chemoradiotherapy Followed by Toripalimab Maintenance Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily participate in and sign informed consent in person.
- Age 18-65, male or non-pregnant female.
- Pathological diagnosis of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, i.e., WHO type II or III).
- First treatment patients who did not receive antitumor therapy had no history of other malignant tumors;
- Stage IVa: TanyN3M0/T4N0-2M0 (8th AJCC/UICC stage)
Key exclusion criteria (13 listed)
- Patients with recurrent and distant metastasis of nasopharyngeal carcinoma.
- The pathology was keratinized squamous cell carcinoma (WHO type I).
- Received systemic or local glucocorticoid therapy within 4 weeks prior to enrollment.
- Participants who had participated in other drug clinical trials within 3 months before treatment.
- Patients with a 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 |
|---|---|---|
| ToripalimabFixed dose: 240mg/ time, add 100ml normal saline, intravenous infusion for 30 minutes (not less than 20 minutes, not more than 60 minutes). The first course of induction chemotherapy (D1) is used on the first day of each cycle, and every 21 days is a course of treatment up to 18 courses or one year. After intravenous infusion of triplelizumab, GP regimen induction chemotherapy was administered at an interval of 30-60 minutes. | Drug | Experimental group |
| AnlotinibOral administration before breakfast, 10mg/ time/day, once a day (d1-14), repeated every 3 weeks, using three courses, one week before radiotherapy discontinuation. Use on the day the first course of induction chemotherapy begins (D1). | Drug | Experimental group |
| Gemcitabine1000mg/m2, D1, D8, add 0.9% normal saline 500ml, intravenous infusion. Every 21 days is a treatment cycle. If the recovery of toxicity in the subject is not sufficient for the next course of chemotherapy, the start of the next course of chemotherapy may be appropriately delayed, but the delay cannot exceed 21 days. The treatment was continued for 3 courses. | Drug | Experimental group |
| CisplatinInduction Chemotherapy: 80mg/m2, D1, add 1000ml 0.9% normal saline, intravenous infusion for 3 hours. Concurrent Chemoradiotherapy100mg/m2, add 5% glucose 500ml, intravenous drip. Use on the first day of each cycle, every 21 days for a treatment cycle | Drug | Experimental group |
| radiationIMRT, 33Fx | Radiation | Experimental group |
Primary outcome
2-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 2 years.
2-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 28 Feb 2025.
- Individual participant dataSharing planned: No. Researchers who has 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab, Anlotinib and Gemcitabine 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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 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 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?
2-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 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 28 Feb 2025.