Locally Advanced Nasopharyngeal CarcinomaPhase 2NCT07085234
Iparomlimab/Tuvorlimab (QL1706) and Modified TPF Regimen for Induction Therapy in LANPC
A Phase 2 study testing Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen in people with Locally Advanced Nasopharyngeal Carcinoma and Immunotherapy, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Locally Advanced Nasopharyngeal Carcinoma, Immunotherapy, Induction Therapy
- What is being tested?
- Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
San-Gang Wu, MD, 865922139531, wusg@xmu.edu.cn
About this study
Official title: The Efficacy and Safety of Iparomlimab/Tuvorlimab (QL1706) Combined With Modified TPF Regimen for Induction Therapy in Locally Advanced Nasopharyngeal Carcinoma
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.
- Being tested
- Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimenDrug
Also called QL-1706, Modified TPF regimen
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rates after induction therapy
Higher scores mean a better outcome.
Measured: From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).
Secondary outcomes (4)
ORR
Higher scores mean a better outcome.
Measured: 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
Higher scores mean a worse outcome.
Measured: From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).
PFS
Higher scores mean a better outcome.
Measured: From the time of enrollment until two years after the completion of the treatment.
OS
Higher scores mean a better outcome.
Measured: From the time of enrollment until two years after the completion of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, San-Gang Wu, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085234
- Sponsor's protocol ID
- 2025-113
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Iparomlimab/Tuvorlimab (QL1706) Combined With Modified TPF Regimen for Induction Therapy in Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07085234
- Acronym / sponsor ID
- 2025-113
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen | Experimental | Drug: Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimenPatients 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimenAlso: QL-1706, Modified TPF regimenInduction 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. | Drug | Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen |
Primary outcome
Complete response rates after induction therapy
Time frame: From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).
Higher scores mean a better outcome.
4 secondary outcomes
ORR
Time frame: 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
Time frame: From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).
PFS
Time frame: From the time of enrollment until two years after the completion of the treatment.
OS
Time frame: From the time of enrollment until two years after the completion of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab/Tuvorlimab(QL-1706) and modified TPF regimen in people with Locally Advanced Nasopharyngeal Carcinoma and Immunotherapy, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rates after induction therapy (time frame: From the time of enrollment to the end of cycle 3 of induction therapy (each cycle is 21 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.