Iparomlimab/Tuvorlimab (QL1706) and Modified TPF Regimen for Induction Therapy in LANPC

NCT07085234 | Recruiting Phase 2 DMC

• 1 other identifier: 2025-113
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Nasopharyngeal Carcinoma; Immunotherapy; Induction Therapy

Outcome Measures

Primary Outcomes (1)

• Complete response rates after induction therapy

  Higher scores mean a better outcome.

  From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).

Secondary Outcomes (4)

• ORR

  From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).

• PFS

  From the time of enrollment until two years after the completion of the treatment.

• OS

  From the time of enrollment until two years after the completion of the treatment

Study Arms (1)

Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen

EXPERIMENTAL

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).

Drug: Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen

Interventions

Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen DRUG

Induction therapy: 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). One cycle lasts for 21 days, and the treatment continues for three consecutive cycles. Concurrent chemotherapy: Cisplatin 80 mg/m², divided on days 1 - 3. One cycle lasts for 21 days, and the treatment continues for two consecutive cycles. Radiotherapy regimen: Whole-course IMRT.

Also known as: QL-1706, Modified TPF regimen

Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 25, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)