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

Fujian Provincial Cancer Hospital

Status and phase: Begins enrollment this month; Phase 2

Conditions: Locally Advanced Nasopharyngeal Carcinoma

Treatments: Drug: Toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT07388836

2026-01-15

Details and patient eligibility

About

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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 3 patient groups

Control Arm

No Intervention group

Description:

Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 1 of each 21-day cycle for 3 cycles.

Experimental Arm

Experimental group

Description:

Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 9 of each 21-day cycle for 3 cycles.

Treatment:

Drug: Toripalimab

Drug: Toripalimab

Exploratory Arm

Experimental group

Description:

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.

Treatment:

Drug: Toripalimab

Drug: Toripalimab