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

January 29, 2023 updated by: Fourth Affiliated Hospital of Guangxi Medical University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangxi
      • Baise, Guangxi, China, 533000
        • Recruiting
        • People's Hospital of Baise
        • Contact:
      • Baise, Guangxi, China, 533099
        • Recruiting
        • Affiliated Hospital of Youjiang Medical University for Nationalities
        • Contact:
      • Guilin, Guangxi, China, 541000
      • Guilin, Guangxi, China, 541000
        • Recruiting
        • Nanxishan Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
      • Liuzhou, Guangxi, China
        • Recruiting
        • The Fourth Affiliated Hospital of Guangxi Medical University
        • Contact:
      • Nanjing, Guangxi, China, 530000
        • Recruiting
        • Second Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Qinzhou, Guangxi, China, 535000
        • Recruiting
        • The First People's Hospital of Qinzhou
        • Contact:
      • Wuzhou, Guangxi, China, 543000
    • Other (Non U.s.)
      • Liuzhou, Other (Non U.s.), China, 545000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 18 to 70.
  2. Pathological type: non-keratinizing carcinoma (World Health Organization criteria).
  3. 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].
  4. ECOG performance score: 0 to 1.
  5. Primary lesions can measurable.
  6. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
  7. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula).
  8. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental: Nimotuzumab arm
Patients will receive induction chemotherapy with nimotuzumab (200mg/w,weekly plus gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT. After 4-6 weeks of the completion of IMRT, adjuvant nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles.
Drug: Nimotuzumab

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
Drug: Gemcitabine
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles
Other Names:
  • GEM
Drug: Cisplatin

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
Radiation: Intensity-modulated radiotherapy
Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day
Other Names:
  • IMRT
ACTIVE_COMPARATOR: Control
Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT.
Drug: Nimotuzumab

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
Drug: Gemcitabine
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles
Other Names:
  • GEM
Drug: Cisplatin

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
Radiation: Intensity-modulated radiotherapy
Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day
Other Names:
  • IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
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.
5 years
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.
5 years
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 years
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.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fourth Affiliated Hospital of Guangxi Medical University

Collaborators

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

Investigators

  • Principal Investigator: Ying Lu, MD, The Fourth Affiliated Hospital of Guangxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2022

Primary Completion (ANTICIPATED)

November 30, 2024

Study Completion (ANTICIPATED)

November 30, 2027

Study Registration Dates

First Submitted

December 24, 2022

First Submitted That Met QC Criteria

January 29, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 29, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZLK3815405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Complete de-identified patient data set

IPD Sharing Time Frame

For 2 years started from 12 months after publication of the primary trial report.

IPD Sharing Access Criteria

Authoritative researchers who provide a methodologically sound proposal for individual participant data meta-analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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