GNT Induction Treatment in Locally Advanced NPC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: gemcitabine,nimotuzumab, toripalimab, gemcitabine, cisplatin.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Gemcitabine Combined With Nimotuzumab and Toripalimab as Induction Treatment Followed by Chemoradiotherapy for Locally Advanced Nasopharyngeal carcinoma-a Multicenter, Randomized Controlled Study
Overview
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
- Drug gemcitabine,nimotuzumab, toripalimab
same as before - Drug gemcitabine, cisplatin
same as before
Primary outcome measures
- overall response rate [Time frame: three weeks after induction therapy]
Secondary outcome measures (3)
- 2-year overall survival [Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months]
- 2-year distant metastasis-free survival [Time frame: 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 local regional recurrence-free survival [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 months]
Eligibility criteria
Inclusion criteria
- 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.
- 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.
- 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)
- Basically normal liver function: serum total bilirubin ≤1.5×ULN; aspartate aminotransferase (AST) ≤2.5×ULN; alanine aminotransferase (ALT) ≤2.5×ULN.
- Signed written informed consent.
Exclusion criteria
- 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.
- Presence of uncontrolled concurrent diseases (such as heart failure, severe lung disease, severe liver disease, mental disease, etc.).
- Known HIV infection, active viral hepatitis, or tuberculosis.
- Major surgery within 90 days before the first dose of the study drug, or planned surgery.
- Allergic to the drugs used in this protocol or their components.
- 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.
- The investigator believes the subject is not suitable for this study.
- Unwilling to participate in this study or unable to sign the informed consent form.
- Live vaccinations within 30 days of dosing.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University — Xi'an
Identifiers
NCT: NCT06026878 · AFMMUChina