Iparomlimab/Tuvorlimab (QL1706) plus modified TPF induction for locally advanced nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, multicenter, single-arm phase 2 study planning to enroll 30 adults with previously untreated, locally advanced nasopharyngeal carcinoma. Participants receive induction therapy with Iparomlimab/Tuvorlimab (QL‑1706) combined with a modified TPF chemotherapy regimen. After induction, patients proceed to standard cisplatin-based concurrent chemoradiotherapy according to clinical practice. The study will collect safety, tolerability, and tumor response data to inform further development of this combination approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: ≥ 18 years old;
* Patients with nasopharyngeal carcinoma diagnosed by pathology (including histology or cytology), with a clinical stage of III - IV (excluding T3N0 - 1) (according to the UICC/AJCC TNM staging system (8th edition));
* No prior systematic treatment (surgery, radiotherapy, chemotherapy, etc.); At least one measurable lesion on imaging examination (according to RECIST criteria version 1.1);
* ECOG PS: 0 - 1 points;
* Expected survival time ≥ 3 months;
* Normal function of major organs, meeting the following criteria:

  1. Blood routine tests should meet the following (without blood transfusion within 14 days):

     1. HB ≥ 100 g/L,
     2. WBC ≥ 3 × 10⁹/L,
     3. ANC ≥ 1.5 × 10⁹/L,
     4. PLT ≥ 100 × 10⁹/L;
  2. Biochemical tests should meet the following criteria:

     1. BIL \< 1.5 times the upper limit of normal (ULN),
     2. ALT and AST \< 2.5 ULN, GPT ≤ 1.5 × ULN;
     3. Serum Cr ≤ 1 ULN, endogenous creatinine clearance rate \> 60 ml/min (Cockcroft - Gault formula);
* Male subjects and women of childbearing potential must use contraception from the start of the first dose of the study drug until 24 weeks after the last dose of the study drug;
* Normal function of major organs, with basically normal blood routine, blood biochemistry and coagulation function tests;
* The investigator believes that the patient will benefit from the treatment in terms of survival;
* The patient voluntarily participates in this study and provides a written informed consent form.

Exclusion Criteria:

* Active, known, or suspected autoimmune diseases;
* Patients with hypertension whose blood pressure cannot be controlled within the normal range with antihypertensive medications (systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 90 mmHg);
* Inherited bleeding tendency or coagulation disorders. Clinically significant bleeding symptoms occurred within 12 weeks before screening or there is a definite bleeding tendency (cumulative blood loss exceeding 50 ml within 24 hours);
* Uncontrolled cardiac clinical symptoms or diseases, such as: (1) Heart failure of NYHA class II or above; (2) Unstable angina; (3) Myocardial infarction within 24 weeks; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
* Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment, active pneumonia with clinical symptoms, or severe pulmonary function impairment;
* Subjects with active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or hepatitis C (positive for hepatitis C antibody and HCV-RNA above the lower limit of detection of the analytical method);
* Subjects with allergic reactions to the drugs used in this study;
* Pregnant or lactating women;
* Other conditions considered by the investigator as unsuitable for participation in this study.

Where it's running

• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.