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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | Toripalimab 240 mg IV on Day 9, every 21-day cycle, for 3 cycles. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 2 cycles of neoadjuvant therapy (21-28 days for each cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The proportion of participants achieving complete response (CR) or partial response (PR) after 2 cycles of neoadjuvant chemo-immunotherapy. | After 2 cycles of neoadjuvant therapy (21-28 days for each cycle) |
| Disease Control Rate |
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Inclusion Criteria:
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
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
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yedong Huang, MD. PhD | Contact | 86+15959678182 | drhuangyd@163.com |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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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).
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| Toripalimab |
| Drug |
Toripalimab 240 mg IV on Day 5 depending, every 21-day cycle, for 3 cycles. |
|
The proportion of participants with CR, PR, or stable disease (SD) after 2 cycles of neoadjuvant chemo-immunotherapy. |
| 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. | 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. | From first dose until 30 days after the end of neoadjuvant therapy |