Actively Recruiting
Iparomlimab/Tuvorlimab (QL1706) and Modified TPF Regimen for Induction Therapy in LANPC
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-07-25
30
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open-label, multicenter, single-arm clinical study. A total of 30 patients with locally advanced nasopharyngeal carcinoma who have not received prior systemic treatment are planned to be enrolled at three centers. After enrollment, the patients will receive induction therapy with Iparomlimab/Tuvorlimab(QL-1706) in combination with a modified TPF regimen, followed by concurrent chemoradiotherapy with cisplatin according to the standards of clinical practice.
CONDITIONS
Official Title
Iparomlimab/Tuvorlimab (QL1706) and Modified TPF Regimen for Induction Therapy in LANPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years old
- Pathological diagnosis of nasopharyngeal carcinoma with clinical stage III-IV (excluding T3N0-1) according to UICC/AJCC TNM (8th edition)
- No prior systemic treatment including surgery, radiotherapy, or chemotherapy
- At least one measurable lesion on imaging according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival time of at least 3 months
- Normal major organ function meeting specified blood routine and biochemical test criteria without recent blood transfusion
- Male and women of childbearing potential agree to use contraception from first dose until 24 weeks after last dose
- Investigator believes patient may benefit from treatment
- Patient voluntarily consents in writing to participate
You will not qualify if you...
- Active, known, or suspected autoimmune diseases
- Uncontrolled hypertension with blood pressure above 160/90 mmHg despite medication
- Inherited bleeding disorders or significant bleeding within 12 weeks prior
- Uncontrolled cardiac conditions including heart failure NYHA class II or higher, unstable angina, recent myocardial infarction, or significant arrhythmias requiring treatment
- Interstitial lung disease, drug-induced or radiation pneumonia requiring steroids, active pneumonia, or severe lung impairment
- Active hepatitis B or C infection above specified viral load thresholds
- Allergic reactions to study drugs
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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