GNT Induction Treatment in Locally Advanced NPC

Launched by AIR FORCE MILITARY MEDICAL UNIVERSITY, CHINA · Sep 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced nasopharyngeal carcinoma (NPC), a type of cancer that affects the area behind the nose. Researchers want to see if a combination of three drugs—gemcitabine, nimotuzumab, and toripalimab—works just as well as the standard treatment, which includes gemcitabine and cisplatin. Participants will be randomly assigned to one of the two treatment groups to compare how well these treatments help reduce cancer.

To be eligible for this trial, participants must be between the ages of 18 and 75 and have a confirmed diagnosis of stage III-IVB NPC. They should also be in good overall health, with specific criteria about their blood counts and organ function. Participants can expect to receive either the new combination treatment or the standard treatment and will be closely monitored throughout the study. It’s important to know that certain health conditions or previous treatments may exclude someone from joining the trial. If eligible, participants will be asked to sign a consent form to ensure they understand the study and agree to take part.

Gender

ALL

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.