Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma

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.

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