Locally Advanced Nasopharyngeal Carcinoma
Conditions
Brief 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. 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.
Interventions
DRUGToripalimab
Toripalimab 240 mg IV on Day 9, every 21-day cycle, for 3 cycles.
Sponsors
Fujian Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | After 2 cycles of neoadjuvant therapy (21-28 days for each cycle) | The proportion of participants achieving complete response (CR) or partial response (PR) after 2 cycles of neoadjuvant chemo-immunotherapy. |
| Disease Control Rate | After 2 cycles of neoadjuvant therapy (21-28 days for each cycle) | The proportion of participants with CR, PR, or stable disease (SD) after 2 cycles of neoadjuvant chemo-immunotherapy. |
| EBV DNA Clearance Rate | After 2 cycles of neoadjuvant therapy (21-28 days for each cycle) | The proportion of participants with undetectable plasma Epstein-Barr virus (EBV) DNA levels after 2 cycles of neoadjuvant chemo-immunotherapy. |
| Incidence of Grade ≥3 Treatment-Related Adverse Events | From first dose until 30 days after the end of neoadjuvant therapy | The frequency of treatment-related adverse events (AEs) of grade 3 or higher, according to CTCAE version 5.0. |
Contacts
CONTACTYedong Huang, MD. PhD
Outcome results
None listed