GNT Induction Treatment in Locally Advanced NPC
ConditionNasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAir Force Military Medical University, China
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 18 to 75 years old.
Pathologically or cytologically confirmed stage III-IVB nasopharyngeal keratinizing squamous cell carcinoma or non-keratinizing squamous cell carcinoma.
Patients suitable for radical radiochemotherapy.
ECOG PS score of 0-1.
Disqualifiers
Patients who have previously undergone immunotherapy or targeted therapy.
Participated in any other interventional clinical trials within 30 days before screening.
History of other malignancies (except for cured skin basal cell carcinoma).
History of primary immunodeficiency.
Trial design
Design model
Parallel
Treatments tested in this trial
gemcitabine,nimotuzumab, toripalimab
Drugsame as before
gemcitabine, cisplatin
Drugsame as before
Treatment groups
228 Participants
are divided into 2 treatment groupsGroup A: gemcitabine, nimotuzumab and toripalimab induction treatmentExperimental treatment 1 intervention
Group B: gemcitabine and cisplatinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
overall response rate
the proportion of patients who achieve complete response and partial response after induction therapy
Time frame
three weeks after induction therapySecondary outcomes
1
2-year overall survival
2-year survival rate of patients enrolled in this study
Time frame
From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months2
2-year distant metastasis-free survival
2-year distant metastasis-free survival rate of patients enrolled in this study
Time frame
From date of randomization until the date of distant metastasis or last follow-up time,, whichever came first, assessed up to 100 months3
2-year local regional recurrence-free survival
2-year local regional recurrence-free survival rate of patients enrolled in this study
Time frame
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 monthsOther outcomes
1
adverse events
treatment-related adverse events during treatment and follow-up time
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov