Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT07135804
Brief Summary:
This is a prospective, multicenter phase II clinical study. The subjects are patients with previously untreated locally advanced nasopharyngeal carcinoma, with clinical staging of IVA, T1-4, N3, M0. The study aims to preliminarily evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injectionin the treatment of these patients.
Detailed Description:
Research Objective: To preliminarily evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection in the treatment of previously untreated locally advanced nasopharyngeal carcinoma patients.
Study Design: Prospective, multicenter phase II clinical study. Study Subjects: Previously untreated locally advanced nasopharyngeal carcinoma patients with clinical stage: IVA, T1-4, N3, M0.
Sample Size: It is assumed that the 3-year distant metastasis free survival (DMFS) rate of T1-4N3M0 nasopharyngeal carcinoma patients after standard treatment is 74%, and the 3-year DMFS rate after combining with Iparomlimab and Tuvonralimab Injection in the induction and adjuvant stages for T1-4N3M0 nasopharyngeal carcinoma patients is 90%. With a two-sided α=0.05 and power of 80%, and considering a 10% dropout rate, the total sample size is calculated to be 45 cases.
Inclusion Criteria: Refer to the corresponding section. Exclusion Criteria: Refer to the corresponding section. Treatment Plan: Eligible subjects are selected according to the inclusion and exclusion criteria. They will receive 3 courses of Iparomlimab and Tuvonralimab Injection during the induction chemotherapy period, undergo standard concurrent chemoradiotherapy as scheduled, and receive 9 cycles of Iparomlimab and Tuvonralimab Injection (5mg/kg, Q3W) in the adjuvant stage. This will continue until the researcher judges that the subject can no longer benefit, the disease progresses, intolerable toxicity occurs, the researcher decides to stop, the subject withdraws informed consent, or death occurs.
Study Endpoints:
Primary Study Endpoint: 3-year distant metastasis-free survival (DMFS). Secondary Study Endpoints: Objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety and tolerability (according to CTCAE 5.0 criteria).
Exploratory Endpoints: Analysis of the correlation between PD-L1 expression and CTLA-4 expression in tumor tissues and the anti-tumor activity of Iparomlimab and Tuvonralimab Injection, and the correlation between EBV-DNA quantification and prognosis.
Statistical Analysis Methods: The chi-square test will be used for comparing rates. Time-event data will be used to estimate the survival function by the Kaplan-Meier method, draw survival curves, and estimate the median time and its 95% confidence interval.
Study:
NCT07135804
Study Brief:
Protocol Section:
NCT07135804