The Efficacy and Safety of Iparomlimab/Tuvorlimab (QL1706) Combined With Modified TPF Regimen for Induction Therapy in Locally Advanced Nasopharyngeal Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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:

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

• HB ≥ 100 g/L,

∙ WBC ≥ 3 × 10⁹/L,

∙ ANC ≥ 1.5 × 10⁹/L,

∙ PLT ≥ 100 × 10⁹/L;

⁃ Biochemical tests should meet the following criteria:

• BIL \< 1.5 times the upper limit of normal (ULN),

∙ ALT and AST \< 2.5 ULN, GPT ≤ 1.5 × ULN;

∙ 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.

Locations
Other Locations
China
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen
Patients will receive three cycles of Albumin-bound paclitaxel 260 mg/m² + cisplatin 75 mg/m² (divided on days 1 - 3) + S1 calculated according to body surface area, taken twice daily (days 1 - 14) + Iparomlimab/Tuvorlimab(QL-1706) 5 mg/kg (day 1).
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Xiamen University

This content was sourced from clinicaltrials.gov