Locally Advanced Nasopharyngeal CarcinomaPhase 2NCT07388836
Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing Toripalimab in people with Locally Advanced Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital.
Trial summary
This is a multicenter, open-label, randomized phase II clinical trial designed to evaluate the optimal timing of toripalimab administration during neoadjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Nasopharyngeal Carcinoma
- What is being tested?
- Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to May 2028
- 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
- Histologically confirmed locoregionally advanced nasopharyngeal carcinoma (AJCC/UICC 8th edition stage II-III)
- At least one measurable target lesion per RECIST 1.1
- ECOG performance status of 0-1
- Estimated life expectancy ≥ 6 months
- Adequate hematologic, hepatic, renal, and coagulation function
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- Negative pregnancy test for women of childbearing potential
- Willingness to use effective contraception during the study and for 12 months after treatment
- Signed informed consent
- Willing and able to comply with study procedures
- Not participating in any other interventional clinical trials during the study period
Who cannot join
- re first dose
- Active or suspected autoimmune disease requiring systemic treatment
- Ongoing systemic immunosuppressive therapy
- Active hepatitis B, hepatitis C, HIV infection, or other serious infections
- History of another malignancy within 5 years (except non-melanoma skin cancer or in situ cervical cancer)
- Pregnant or breastfeeding women
- Inability or unwillingness to use contraception as required
- Life expectancy < 6 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Phase II Clinical Trial to Optimize the Timing of Immune Checkpoint Inhibitor Administration During Neoadjuvant Chemotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
This is a multicenter, open-label, randomized phase II clinical trial designed to evaluate the optimal timing of toripalimab administration during neoadjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. Participants will receive gemcitabine and cisplatin (GP) chemotherapy combined with toripalimab administered on different days (Day 1, Day 5, or Day 9) to compare treatment responses. The neoadjuvant phase includes 3 cycles of 21 days each, followed by concurrent chemoradiotherapy. The estimated enrollment period is from March 2026 to March 2028.
- Being tested
- Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Toripalimab 240 mg IV on Day 9, every 21-day cycle, for 3 cycles.
ToripalimabDrug
Toripalimab 240 mg IV on Day 5 depending, every 21-day cycle, for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 1 of each 21-day cycle for 3 cycles. |
| Experimental Arm | Experimental | Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 9 of each 21-day cycle for 3 cycles. Receives: Drug: Toripalimab |
| Exploratory Arm | Experimental | Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 5 of each 21-day cycle for 3 cycles. This arm is exploratory in nature with a smaller sample size. Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
The proportion of participants achieving complete response (CR) after 2 cycles of neoadjuvant chemotherapy combined with toripalimab, as assessed by RECIST or institutional imaging criteria.
Measured: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)
Secondary outcomes (4)
Objective Response Rate
The proportion of participants achieving complete response (CR) or partial response (PR) after 2 cycles of neoadjuvant chemo-immunotherapy.
Measured: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)
Disease Control Rate
The proportion of participants with CR, PR, or stable disease (SD) after 2 cycles of neoadjuvant chemo-immunotherapy.
Measured: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)
EBV DNA Clearance Rate
The proportion of participants with undetectable plasma Epstein-Barr virus (EBV) DNA levels after 2 cycles of neoadjuvant chemo-immunotherapy.
Measured: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)
Incidence of Grade ≥3 Treatment-Related Adverse Events
The frequency of treatment-related adverse events (AEs) of grade 3 or higher, according to CTCAE version 5.0.
Measured: From first dose until 30 days after the end of neoadjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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
- Model description
- Participants will be assigned in a 1:1:1 ratio to three parallel arms receiving gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 1 (control), Day 5 (exploratory), or Day 9 (experimental).
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Huang Chaobin, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388836
- Sponsor's protocol ID
- 2026-01-15
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 5 Feb 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Phase II Clinical Trial to Optimize the Timing of Immune Checkpoint Inhibitor Administration During Neoadjuvant Chemotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07388836
- Acronym / sponsor ID
- 2026-01-15
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 5 Feb 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 is a multicenter, open-label, randomized phase II clinical trial designed to evaluate the optimal timing of toripalimab administration during neoadjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. Participants will receive gemcitabine and cisplatin (GP) chemotherapy combined with toripalimab administered on different days (Day 1, Day 5, or Day 9) to compare treatment responses. The neoadjuvant phase includes 3 cycles of 21 days each, followed by concurrent chemoradiotherapy. The estimated enrollment period is from March 2026 to March 2028.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be assigned in a 1:1:1 ratio to three parallel arms receiving gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 1 (control), Day 5 (exploratory), or Day 9 (experimental).
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 1 of each 21-day cycle for 3 cycles. |
| Experimental Arm | Experimental | Drug: ToripalimabParticipants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 9 of each 21-day cycle for 3 cycles. |
| Exploratory Arm | Experimental | Drug: ToripalimabParticipants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 5 of each 21-day cycle for 3 cycles. This arm is exploratory in nature with a smaller sample size. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18 and 70 years
- Histologically confirmed locoregionally advanced nasopharyngeal carcinoma (AJCC/UICC 8th edition stage II-III)
- At least one measurable target lesion per RECIST 1.1
- ECOG performance status of 0-1
- Estimated life expectancy ≥ 6 months
Key exclusion criteria (8 listed)
- re first dose
- Active or suspected autoimmune disease requiring systemic treatment
- Ongoing systemic immunosuppressive therapy
- Active hepatitis B, hepatitis C, HIV infection, or other serious infections
- History of another malignancy within 5 years (except non-melanoma skin cancer or in situ cervical cancer)
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 IV on Day 9, every 21-day cycle, for 3 cycles. | Drug | Experimental Arm |
| ToripalimabToripalimab 240 mg IV on Day 5 depending, every 21-day cycle, for 3 cycles. | Drug | Exploratory Arm |
Primary outcome
Complete Response Rate
Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)
The proportion of participants achieving complete response (CR) after 2 cycles of neoadjuvant chemotherapy combined with toripalimab, as assessed by RECIST or institutional imaging criteria.
4 secondary outcomes
Objective Response Rate
Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)
Disease Control Rate
Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)
EBV DNA Clearance Rate
Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)
Incidence of Grade ≥3 Treatment-Related Adverse Events
Time frame: From first dose until 30 days after the end of neoadjuvant therapy
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 5 Feb 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab in people with Locally Advanced Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital.
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 11 inclusion and 8 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 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yedong Huang, MD. PhD (86+15959678182, drhuangyd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)). 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 5 Feb 2026.