Clinical trial · Interventional
Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 1 of each 21-day cycle for 3 cycles.
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- Participants receive gemcitabine and cisplatin chemotherapy combined with toripalimab administered on Day 9 of each 21-day cycle for 3 cycles.
- interventionNames
- Drug: Toripalimab
- type
- EXPERIMENTAL
- label
- Exploratory Arm
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available