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New treatment option for Locally Advanced Nasopharyngeal Carcinoma
Official title Iparomlimab/Tuvorlimab (QL1706) and Modified TPF Regimen for Induction Therapy in LANPC
ClinicalTrials.gov ID: NCT07085234
What this study is testing
What is Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen?
Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen is an investigational medicine, given as an once-daily, being studied as a potential treatment for locally advanced nasopharyngeal carcinoma.
Also referred to as QL-1706, Modified TPF regimen.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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 -...
- No prior systematic treatment (surgery, radiotherapy, chemotherapy, etc.); At least one measurable lesion on imaging examination (according to RECIST...
- ECOG PS: 0 - 1 points;
- Expected survival time ≥ 3 months;
You likely can't join 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...
- Inherited bleeding tendency or coagulation disorders. Clinically significant bleeding symptoms occurred within 12 weeks before screening or there is...
- Uncontrolled cardiac clinical symptoms or diseases, such as: (1) Heart failure of NYHA class II or above; (2) Unstable angina; (3) Myocardial...
- Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment, active pneumonia with clinical symptoms, or...
- people 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...
See the full eligibility 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:
- 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 people 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.
- 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...
- 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...
- Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment, active pneumonia with clinical symptoms, or severe pulmonary function impairment;
- people 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);
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.