Iparomlimab and Tuvonralimab Injection for Untreated Locally Advanced Nasopharyngeal Carcinoma (NCT07135804) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Iparomlimab and Tuvonralimab Injection for Untreated Locally Advanced Nasopharyngeal Carcinoma
45 participantsStarted 2025-09-01
Plain-language 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.
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
. Absolute neutrophil count (ANC) ≥ 1.5×10⁹ /L;
. Platelets ≥ 100×10⁹ /L;
. Hemoglobin ≥ 9g/dL;
. Serum albumin ≥ 2.8g/dL;
. Total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; if there is liver metastasis, ALT and/or AST ≤ 5×ULN; if there is liver metastasis or bone metastasis, AKP ≤ 5×ULN;
. Serum creatinine ≤ 1.5×ULN or creatinine clearance rate \> 60 mL/min (Cockcroft-Gault, see Appendix II);
. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (screening is allowed for those receiving stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected therapeutic range of anticoagulants)
Exclusion criteria
. Alopecia;
. Pigmentation;
. Peripheral neurotoxicity has recovered to \< CTCAE grade 2;
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
3-year distant metastasis-free survival (DMFS) as assessed by imaging examinations (including CT, MRI, PET-CT) and clinical evaluations to determine the time from randomization to the first occurrence of distant metastasis or death from any cause
Timeframe: Up to 3 years after enrollment (each follow-up cycle is 3 months for the first two years, 6 months for the third year)
2
Objective response rate (ORR) of the tumor as assessed by RECIST 1.1 criteria, including complete response (CR) and partial response (PR) confirmed by imaging examinations (CT, MRI)
Timeframe: Every 9 weeks during treatment (each treatment cycle is 3 weeks) and at the end of treatment
Trial details
NCT IDNCT07135804
SponsorSecond Affiliated Hospital of Nanchang University