Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT07135804
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iparomlimab and Tuvonralimab Injection for Untreated Locally Advanced Nasopharyngeal Carcinoma
Sponsor:
Second Affiliated Hospital of Nanchang University
Organization:
Study Overview
Official Title:
A Phase II Prospective, Single-Arm, Multicenter Clinical Study of Iparomlimab and Tuvonralimab Injection in the Treatment of Patients With Previously Untreated Locally Advanced Nasopharyngeal Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: