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NCT Number: NCT06026878

GNT Induction Treatment in Locally Advanced NPC

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Xi'an, Shaanxi, 710032, China

Location status: Recruiting

Location contact

Jian Zang, M.D.,Ph.D

SUB_INVESTIGATOR

Mei Shi, MD

CONTACT

[email protected]

+86-029-84775425

Mei Shi, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gemcitabine,nimotuzumab, toripalimab

Drug

same as before

Other names: GNT

Gemcitabine, Cisplatin

Drug

same as before

Other names: GP

Primary outcomes

  1. overall response rate

    Time frame: three weeks after induction therapy

    the proportion of patients who achieve complete response and partial response after induction therapy

Secondary outcomes

  1. 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 survival rate of patients enrolled in this study

  2. 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 distant metastasis-free survival rate of patients enrolled in this study

  3. 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

    2-year local regional recurrence-free survival rate of patients enrolled in this study

Other outcomes

  1. adverse events

    Time frame: through study completion, an average of 1 year

    treatment-related adverse events during treatment and follow-up time

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Gemcitabine Combined With Nimotuzumab and Toripalimab as Induction Treatment Followed by Chemoradiotherapy for Locally Advanced Nasopharyngeal carcinoma-a Multicenter, Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Sep 7, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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