Nasopharyngeal CarcinomaPhase 2NCT06592599
Gemcitabine + Docetaxel + Toripalimab Induction in Epstein-Barr Virus (EBV) Associated Nasopharyngeal Carcinoma(NPC)
A Phase 2 study testing Toripalimab and Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation in people with Nasopharyngeal Carcinoma, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the research is to test the safety and efficacy of the investigational drug in human subjects with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Toripalimab and Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2024to Jan 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8
- Prior therapy: None for NPC permitted
- Life expectancy: 3 months at least
- Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months after the last dose.
- ECOG Performance Status of 0,1, or 2
- Age: At least 18 years old.
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- CBC/differential obtained within 21 days prior to day 1 of treatment, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3;
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
- Adequate hepatic function within 21 days prior to day 1 of treatment, defined as follows:
- Total bilirubin ≤ 1.5 x institutional ULN;
- AST and ALT ≤ 1.5 x institutional ULN;
- Adequate renal function within 21 days prior to day 1 of treatment, defined as follows:
- Serum creatinine ≤ 1.5 mg/dl or calculated or measured creatinine clearance (CC) ≥ 50 ml/min
- Negative serum pregnancy test within 14 days prior to day 1 of treatment for women of childbearing potential
- Ability to understand and the willingness to personally sign the written IRB approved informed consent document.
Who cannot join
- Prior systemic anticancer treatment for NPC
- Prior radiation to head and neck region or regions necessitating overlapping fields
- Concurrent use of any anti- cancer treatment, standard, alternative or investigational.
- History of allergic reactions to any agents in this study
- Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition.
- Pregnant or breastfeeding
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- Severe, active co-morbidity, defined as follows:
- Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy;
- Unstable angina and/or uncontrolled congestive heart failure within past 6 months;
- Myocardial infarction within the last 6 months;
- Current acute bacterial or fungal infection requiring intravenous antibiotics; note that patients receiving IV antibiotics or currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible.
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to day 1 of treatment;
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
- Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed
- ≥ grade 2 peripheral sensory neuropathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
Elizabeth Winters, 650-723-6372, ewinters@stanford.edu
A. Dimitrios Colevas, MD
About this study
Official title: A Safety, Feasibility and Efficacy Study of Gemcitabine Plus Docetaxel Plus Toripalimab (GDT) Induction as Part of a Curative Sequential Chemoradiation for Patients With Locoregional EBV Associated Nasopharyngeal Carcinoma (NPC)
The purpose of the research is to test the safety and efficacy of the investigational drug in human subjects with cancer.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Toripalimab, Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation
- Keywords
- gemcitabine, docetaxel, toripalimab
- 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 will be administered 240 mg intravenously every three weeks in combination with the induction chemotherapy regimen for 3 cycles, and for 9 cycles as adjuvant treatment following radiation as specified in the overall sequential treatment plan.
Concurrent Chemoradiation and Adjuvant treatment following ChemoradiationRadiation
Radiation treatment will be initiated 3-6 weeks following day 1 of the last induction cycle using institutional standards of care and support as follows:
Intensity modulated radiotherapy, 70 Gy in 33 fractions M-F once daily plus cisplatin 40 mg/m2 IV weekly for up to 7 doses.
Following the completion of concurrent chemoradiation, capecitabine will be administered using institutional standards of care as follows:
Capecitabine 650 mg/m2 PO BID x 12 months beginning 12 to 16 weeks following the end of radiation treatment. Dose reductions and discontinuance of capecitabine will be according to the standard of care applied at the treating institution.
Adjuvant Toripalimab 240 mg IV q 21d x 9 maximum doses will be initiated concurrently with the initiation of adjuvant capecitabine, beginning 12-16 weeks following the end of radiation.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, Docetaxel and Capecitabine | Experimental | Patients will receive three q 21-day cycles of gemcitabine 1000 mg/m2 plus docetaxel 75 mg/m2 plus toripalimab 240 mg, followed by radiation to 70 Gy plus concurrent weekly cisplatin, 40 mg/m2 up to 7 doses, followed by adjuvant capecitabine 650 mg/m2 BID for one year plus toripalimab 240 mg q 21 days for 9 doses. Receives: Drug: Toripalimab; Radiation: Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction chemotherapy completion rate
Induction chemotherapy completion rate, defined as the proportion of patients who complete three cycles of chemoimmunotherapy within 12 weeks of initiation. Completion is defined for induction as receiving all 3 cycles as planned, including protocol specified dose reduction and delays. .
Measured: 3 years
Radiation completion rate
Radiation completion rate, defined as the proportion of patients who complete specified radiation within 8 weeks of radiation initiation. Radiation completion is defined as completion of planned doses of radiation.
Measured: 3 years
Secondary outcomes (2)
Overall Response (ORD) rate following induction
OR rate following induction, defined as the proportion of patients who achieve at least a RECIST defined PR within 12 weeks of induction chemotherapy initiation.
Measured: 3 years
Complete Response (CR) rate following radiation
CR rate following radiation, defined as the proportion of patients who achieve a RECIST defined CR within 16 weeks following the end of radiation therapy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Sep 2024
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (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 Stanford 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A. Dimitrios Colevas, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592599
- Sponsor's protocol ID
- IRB-75587
- Other IDs
- NCI-2025-00939
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Feasibility and Efficacy Study of Gemcitabine Plus Docetaxel Plus Toripalimab (GDT) Induction as Part of a Curative Sequential Chemoradiation for Patients With Locoregional EBV Associated Nasopharyngeal Carcinoma (NPC)
- ClinicalTrials.gov ID
- NCT06592599
- Acronym / sponsor ID
- IRB-75587
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- gemcitabine, docetaxel, toripalimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research is to test the safety and efficacy of the investigational drug in human subjects with cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, Docetaxel and Capecitabine | Experimental | Drug: Toripalimab, Radiation: Concurrent Chemoradiation and Adjuvant treatment following ChemoradiationPatients will receive three q 21-day cycles of gemcitabine 1000 mg/m2 plus docetaxel 75 mg/m2 plus toripalimab 240 mg, followed by radiation to 70 Gy plus concurrent weekly cisplatin, 40 mg/m2 up to 7 doses, followed by adjuvant capecitabine 650 mg/m2 BID for one year plus toripalimab 240 mg q 21 days for 9 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8
- Prior therapy: None for NPC permitted
- Life expectancy: 3 months at least
- Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months after the last dose.
- ECOG Performance Status of 0,1, or 2
Key exclusion criteria (15 listed)
- Prior systemic anticancer treatment for NPC
- Prior radiation to head and neck region or regions necessitating overlapping fields
- Concurrent use of any anti- cancer treatment, standard, alternative or investigational.
- History of allergic reactions to any agents in this study
- Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition.
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 will be administered 240 mg intravenously every three weeks in combination with the induction chemotherapy regimen for 3 cycles, and for 9 cycles as adjuvant treatment following radiation as specified in the overall sequential treatment plan. | Drug | Gemcitabine, Docetaxel and Capecitabine |
| Concurrent Chemoradiation and Adjuvant treatment following ChemoradiationRadiation treatment will be initiated 3-6 weeks following day 1 of the last induction cycle using institutional standards of care and support as follows: Intensity modulated radiotherapy, 70 Gy in 33 fractions M-F once daily plus cisplatin 40 mg/m2 IV weekly for up to 7 doses. Following the completion of concurrent chemoradiation, capecitabine will be administered using institutional standards of care as follows: Capecitabine 650 mg/m2 PO BID x 12 months beginning 12 to 16 weeks following the end of radiation treatment. Dose reductions and discontinuance of capecitabine will be according to the standard of care applied at the treating institution. Adjuvant Toripalimab 240 mg IV q 21d x 9 maximum doses will be initiated concurrently with the initiation of adjuvant capecitabine, beginning 12-16 weeks following the end of radiation. | Radiation | Gemcitabine, Docetaxel and Capecitabine |
Primary outcome
Induction chemotherapy completion rate
Time frame: 3 years
Induction chemotherapy completion rate, defined as the proportion of patients who complete three cycles of chemoimmunotherapy within 12 weeks of initiation. Completion is defined for induction as receiving all 3 cycles as planned, including protocol specified dose reduction and delays. .
Radiation completion rate
Time frame: 3 years
Radiation completion rate, defined as the proportion of patients who complete specified radiation within 8 weeks of radiation initiation. Radiation completion is defined as completion of planned doses of radiation.
2 secondary outcomes
Overall Response (ORD) rate following induction
Time frame: 3 years
Complete Response (CR) rate following radiation
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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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.
A. Dimitrios Colevas, MD principal investigator
Stanford University
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 and Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation in people with Nasopharyngeal Carcinoma, run by Stanford University at 1 site in United States.
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 17 inclusion and 15 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 23 Jun 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 United States. 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 Elizabeth Winters ((650) 723-6372, ewinters@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction chemotherapy completion rate (time frame: 3 years). The study lists 2 primary outcomes in all. 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 23 Jun 2026.