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

NCT07388836 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2026-01-15
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Objective Response Rate

  After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)

• Disease Control Rate

  After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)

• EBV DNA Clearance Rate

  After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)

• Incidence of Grade ≥3 Treatment-Related Adverse Events

  From first dose until 30 days after the end of neoadjuvant therapy

Study Arms (3)

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.

Drug: Toripalimab

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.

Drug: Toripalimab

Interventions

Toripalimab DRUG

Toripalimab 240 mg IV on Day 9, every 21-day cycle, for 3 cycles.

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Interventions

toripalimab

Central Study Contacts

Yedong Huang, MD. PhD

CONTACT

86+15959678182; drhuangyd@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share