Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopha… (NCT07388836) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma
198 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete Response Rate
Timeframe: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)