Iparomlimab/Tuvorlimab (QL1706) and Modified TPF Regimen for Induction Therapy in LANPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen
DrugInduction 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete response rates after induction therapy
Higher scores mean a better outcome.
Time frame
From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).Secondary outcomes
1
ORR
Higher scores mean a better outcome.
Time frame
From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).2
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Higher scores mean a worse outcome.
Time frame
From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).3
PFS
Higher scores mean a better outcome.
Time frame
From the time of enrollment until two years after the completion of the treatment.4
OS
Higher scores mean a better outcome.
Time frame
From the time of enrollment until two years after the completion of the treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov