Actively Recruiting
The Efficacy and Safety of Iparomlimab/Tuvorlimab (QL1706) Combined With Modified TPF Regimen for Induction Therapy in Locally Advanced Nasopharyngeal Carcinoma
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-07-25
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach for patients with locally advanced nasopharyngeal carcinoma who have not received prior systemic therapy. This prospective, open-label, multicenter, single-arm clinical study aims to assess the effects of combining Iparomlimab/Tuvorlimab (QL-1706) with a modified TPF chemotherapy regimen followed by standard concurrent chemoradiotherapy. The study is led by The First Affiliated Hospital of Xiamen University and involves 30 patients across three centers. Participants will receive three cycles of induction therapy including Albumin-bound paclitaxel, cisplatin, S1 oral medication based on body surface area, and Iparomlimab/Tuvorlimab administered once per cycle. Each cycle lasts 21 days. Afterward, patients will undergo two cycles of concurrent chemotherapy with cisplatin and a full course of intensity-modulated radiotherapy (IMRT) as per clinical standards. During the study, patients will be closely monitored for complete response rates after induction therapy, overall response rates, treatment-related side effects, progression-free survival, and overall survival for up to two years post-treatment. Assessments include imaging to measure tumor response and regular clinical evaluations. Total participation involves initial enrollment through the end of treatment and follow-up monitoring for two years.
CONDITIONS
Brief 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 years or older
- Diagnosed with nasopharyngeal carcinoma by pathology with clinical stage III to IV (excluding T3N0-1) according to UICC/AJCC TNM 8th edition
- No prior systemic treatment such as surgery, radiotherapy, or chemotherapy
- At least one measurable tumor lesion on imaging per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival time of at least 3 months
- Normal major organ function with blood tests meeting specified thresholds for hemoglobin, white blood cells, neutrophils, and platelets
- Liver function with bilirubin less than 1.5 times upper limit, ALT and AST below 2.5 times upper limit, GPT below 1.5 times upper limit
- Kidney function with serum creatinine less than or equal to normal limit and creatinine clearance above 60 ml/min
- Use of contraception for male and women of childbearing potential from first dose until 24 weeks after last dose
- Normal coagulation and blood biochemistry tests
- Investigator believes patient will benefit in terms of survival
- Voluntary participation with signed informed consent
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 recent significant bleeding within 12 weeks
- Uncontrolled heart issues such as heart failure class II or above, unstable angina, recent myocardial infarction, or arrhythmias requiring treatment
- Lung diseases including interstitial lung disease, drug-induced or radiation pneumonia requiring steroids, active pneumonia, or severe lung impairment
- Active hepatitis B or C infections as defined by viral load or antibody status
- Allergic reactions to study drugs
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 15 weeks (three 21-day cycles of induction therapy plus two 21-day cycles of concurrent chemotherapy)
Participants receive induction therapy with three cycles of albumin-bound paclitaxel, cisplatin, S1, and Iparomlimab/Tuvorlimab, followed by concurrent chemotherapy with cisplatin and radiotherapy.
Multiple visits over approximately 15 weeks during treatment cycles
Duration - Up to 2 years after treatment completion
Participants are monitored for progression-free survival and overall survival for up to two years after completing treatment.
Periodic visits over two years for monitoring
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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