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

Starting soon · Phase 2

Conditions studied: Locally Advanced Nasopharyngeal Carcinoma

In brief

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.

Key facts

Study ID

NCT07388836

Run by

Fujian Cancer Hospital

People needed

198

Starts

2026-03-01

Expected to finish

2028-05-01

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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