NCT06026878 GNT Induction Treatment in Locally Advanced NPC
| NCT ID | NCT06026878 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Air Force Military Medical University, China |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 228 participants in total. It began in 2023-09-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare overall response rate between gemcitabine, nimotuzumab and toripalimab as induction treatment and gemcitabine combined with cisplatine in paitents with locally advanced nasopharyngeal carcinoma. It aims to answer whether gemcitabine, nimotuzumab and toripalimab as induction treatment show non-inferiority compared to GP induction chemotherapy. Participants will be randomly divided into two induction treatment groups.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 75 years old. 2. Pathologically or cytologically confirmed stage III-IVB nasopharyngeal keratinizing squamous cell carcinoma or non-keratinizing squamous cell carcinoma. 3. Patients suitable for radical radiochemotherapy. 4. ECOG PS score of 0-1. 5. According to the RECIST 1.1 criteria, there is at least one measurable lesion. Basic hematological parameters are normal: white blood cell count ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L. 6. Basically normal renal function: serum creatinine ≤1.5×ULN or creatinine clearance rate (CrCl) \> 60 mL/min (using the Cockcroft-Gault formula): For females: CrCl = (140-age) x weight (kg) x 0.85 / (72 x Scr mg/dl) For males: CrCl = (140-age) x weight (kg) x 1.00 / (72 x Scr mg/dl) 7. Basically normal liver function: serum total bilirubin ≤1.5×ULN; aspartate aminotransferase (AST) ≤2.5×ULN; alanine aminotransferase (ALT) ≤2.5×ULN. 8. Signed written informed consent. Exclusion Criteria: 1. Patients who have previously undergone immunotherapy or targeted therapy. 2. Participated in any other interventional clinical trials within 30 days before screening. 3. History of other malignancies (except for cured skin basal cell carcinoma). 4. History of primary immunodeficiency. 5. Presence of uncontrolled concurrent diseases (such as heart failure, severe lung disease, severe liver disease, mental disease, etc.). 6. Known HIV infection, active viral hepatitis, or tuberculosis. 7. Major surgery within 90 days before the first dose of the study drug, or planned surgery. 8. Allergic to the drugs used in this protocol or their components. 9. Pregnant (confirmed by blood or urine HCG tests) or breastfeeding women, or those of childbearing age unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment. 10. The investigator believes the subject is not suitable for this study. 11. Unwilling to participate in this study or unable to sign the informed consent form. 12. Live vaccinations within 30 days of dosing.
Frequently Asked Questions
Who can join the NCT06026878 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06026878 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 228 participants.
Is NCT06026878 currently recruiting?
Yes, NCT06026878 is actively recruiting participants. Visit ClinicalTrials.gov or contact Air Force Military Medical University, China to inquire about joining.
Where is the NCT06026878 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06026878 clinical trial?
NCT06026878 is sponsored by Air Force Military Medical University, China. The trial plans to enroll 228 participants.