Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toripalimab, Toripalimab.
- Who it may be relevant to
- Registry conditions: Locally Advanced Nasopharyngeal Carcinoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug Toripalimab
Toripalimab 240 mg IV on Day 9, every 21-day cycle, for 3 cycles. - Drug Toripalimab
Toripalimab 240 mg IV on Day 5 depending, every 21-day cycle, for 3 cycles.
Primary outcome measures
- Complete Response Rate [Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)]
Secondary outcome measures (4)
- Objective Response Rate [Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)]
- Disease Control Rate [Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)]
- EBV DNA Clearance Rate [Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)]
- Incidence of Grade ≥3 Treatment-Related Adverse Events [Time frame: From first dose until 30 days after the end of neoadjuvant therapy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07388836 · 2026-01-15