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NCT Number: NCT07388836

Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for 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.

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Key information

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toripalimab

Drug

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

Primary outcomes

  1. Complete Response Rate

    Time frame: 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 outcomes

  1. Objective Response Rate

    Time frame: 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.

  2. Disease Control Rate

    Time frame: 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.

  3. EBV DNA Clearance Rate

    Time frame: 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.

  4. Incidence of Grade ≥3 Treatment-Related Adverse Events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yedong Huang, MD. PhD

CONTACT

[email protected]

86+15959678182

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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