Nasopharyngeal Carcinoma
Conditions
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.
Interventions
DRUGgemcitabine,nimotuzumab, toripalimab
same as before
same as before
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | three weeks after induction therapy | the proportion of patients who achieve complete response and partial response after induction therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year overall survival | From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months | 2-year survival rate of patients enrolled in this study |
| 2-year distant metastasis-free survival | From date of randomization until the date of distant metastasis or last follow-up time,, whichever came first, assessed up to 100 months | 2-year distant metastasis-free survival rate of patients enrolled in this study |
| 2-year local regional recurrence-free survival | From date of randomization until the date of local and/or lymph node recurrence or last follow-up time,, whichever came first, assessed up to 100 months | 2-year local regional recurrence-free survival rate of patients enrolled in this study |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse events | through study completion, an average of 1 year | treatment-related adverse events during treatment and follow-up time |
Countries
China
Outcome results
None listed