GNT Induction Treatment in Locally Advanced NPC

Last updated: September 5, 2023
Sponsor: Air Force Military Medical University, China
Overall Status: Active - Recruiting

Phase

3

Condition

Carcinoma

Nasopharyngeal Cancer

Treatment

gemcitabine,nimotuzumab, toripalimab

gemcitabine, cisplatin

Clinical Study ID

NCT06026878
AFMMUChina
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  1. Age 18 to 75 years old.
  2. Pathologically or cytologically confirmed stage III-IVB nasopharyngeal keratinizingsquamous 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. Basichematological parameters are normal: white blood cell count ≥4×10^9/L; absoluteneutrophil 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 clearancerate (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; aspartateaminotransferase (AST) ≤2.5×ULN; alanine aminotransferase (ALT) ≤2.5×ULN.
  8. Signed written informed consent.

Exclusion

Exclusion Criteria:

  1. Patients who have previously undergone immunotherapy or targeted therapy.
  2. Participated in any other interventional clinical trials within 30 days beforescreening.
  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 lungdisease, 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 plannedsurgery.
  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 ofchildbearing age unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the lasttrial 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.

Study Design

Total Participants: 228
Treatment Group(s): 2
Primary Treatment: gemcitabine,nimotuzumab, toripalimab
Phase: 3
Study Start date:
September 01, 2023
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

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