Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFujian Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 70 years
Disqualifiers
re first dose
Trial design
Design model
Parallel
Treatments tested in this trial
Toripalimab
DrugToripalimab 240 mg IV on Day 9, every 21-day cycle, for 3 cycles.
Toripalimab
DrugToripalimab 240 mg IV on Day 5 depending, every 21-day cycle, for 3 cycles.
Treatment groups
198 Participants
are divided into 3 treatment groupsGroup A: Control ArmNo intervention 0 interventions
Group B: Experimental ArmExperimental treatment 1 intervention
Group C: Exploratory ArmExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)Secondary outcomes
1
Objective Response Rate
The proportion of participants achieving complete response (CR) or partial response (PR) after 2 cycles of neoadjuvant chemo-immunotherapy.
Time frame
After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)2
Disease Control Rate
The proportion of participants with CR, PR, or stable disease (SD) after 2 cycles of neoadjuvant chemo-immunotherapy.
Time frame
After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)3
EBV DNA Clearance Rate
The proportion of participants with undetectable plasma Epstein-Barr virus (EBV) DNA levels after 2 cycles of neoadjuvant chemo-immunotherapy.
Time frame
After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)4
Incidence of Grade ≥3 Treatment-Related Adverse Events
The frequency of treatment-related adverse events (AEs) of grade 3 or higher, according to CTCAE version 5.0.
Time frame
From first dose until 30 days after the end of neoadjuvant therapyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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