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NCT Number: NCT05717790

Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. This is a multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.

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Key information

Conditions

Nasopharyngeal Carcinoma by AJCC V8 Stage Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma 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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Youjiang Medical University for Nationalities, Baise City, Guangxi, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18 to 70.
  • Pathological type: non-keratinizing carcinoma (World Health Organization criteria).
  • Diagnosed with LANPC (stage III-IV, except for patients with T3N0)) according to the 8th edition clinical staging system of the American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC].
  • ECOG performance score: 0 to 1.
  • Primary lesions can measurable.
  • Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
  • Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula).
  • Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.

Exclusion criteria

  • Primary lesions or lymph node have been operated (except of operation for biopsy).
  • Previous Received other anti EGFR monoclonal antibody treatment;Previous chemotherapy or immunization therapy.
  • Other malignant tumor.
  • Participation in other interventional clinical trials within 1 month.
  • History of Serious lung or heart disease.
  • Pregnant or breast-feeding women and women who refused to take contraceptive method.
  • Drug abuse or alcohol addiction.
  • History of serious allergic or allergy.
  • Refused or can't signed informed consent form.
  • Other patients who are considered ineligible for the study by the investigator.

Treatment and study plan

Nimotuzumab

Drug

Drug: Nimotuzumab Experimental: Nimotuzumab arm Induction chemotherapy:Nimotuzumab 200mg will be given weekly for 6 cycles, started on day 1 of induction chemotherapy.

Concurrent chemotherapy: Nimotuzumab 200mg/week in concurrent with IMRT. Adjuvant therapy: Nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles.

Active Comparator: Control Nimotuzumab 200mg/week in concurrent with IMRT .

Other names: h-R3, BIOMAb EGFR

Gemcitabine

Drug

Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles

Other names: GEM

Cisplatin

Drug

Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles.

Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.

Other names: DDP

Intensity-Modulated Radiotherapy

Radiation

Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day

Other names: IMRT

Primary outcomes

  1. overall survival(OS)

    Time frame: 5 years

    Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.OS will be measured by the Method of Kaplan and Meier.

Secondary outcomes

  1. Tumor control probability (TCP)

    Time frame: 5 years

    Tumor control probability is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.

  2. Disease-free survival(DFS)

    Time frame: 5 years

    DFS is defined as the time from randomization to the first documented disease progression or death due to disease progression per RECIST 1.1. DFS will be measured by the Method of Kaplan and Meier.

  3. Locoregional failure-free survival(LRRFS)

    Time frame: 5 years

    LRRFS is defined as the time from randomization to the date of locoregional relapse per RECIST 1.1. LRRFS will be measured by the Method of Kaplan and Meier.

  4. Distant Metastasis-free survival(DMFS)

    Time frame: 5 years

    DMFS is defined as the time from randomization to the date of first distant metastasis. DMFS will be measured by the Method of Kaplan and Meier.

  5. Incidence rate of investigator-reported adverse events (AEs)

    Time frame: 5 years

    Analysis of investigator-reported adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 and radiation therapy oncology group (RTOG) toxicity criteria.

  6. Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)

    Time frame: 5 years

    Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Lu, MD

CONTACT

[email protected]

+8607723815405

Sponsors and collaborators

Lead sponsor

Fourth Affiliated Hospital of Guangxi Medical University

Other

Collaborators

  • Guilin Medical University, China
  • LiuZhou People's Hospital
  • People's Hospital of Baise
  • People's Hospital of Guangxi Zhuang Autonomous Region
  • Second Affiliated Hospital of Guangzhou Medical University
  • The First People's Hospital of Qinzhou
  • Wuzhou Red Cross Hospital
  • Youjiang Medical College for Nationalities

Registry information

Official study title

Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation and Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Feb 8, 2023
Registry last updated
Feb 8, 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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