Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation and Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma
1 other identifier
interventional
288
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 24, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
ExpectedFebruary 8, 2023
December 1, 2022
2 years
December 24, 2022
January 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival(OS)
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 Outcomes (6)
Tumor control probability (TCP)
5 years
Disease-free survival(DFS)
5 years
Locoregional failure-free survival(LRRFS)
5 years
Distant Metastasis-free survival(DMFS)
5 years
Incidence rate of investigator-reported adverse events (AEs)
5 years
- +1 more secondary outcomes
Study Arms (2)
Experimental: Nimotuzumab arm
EXPERIMENTALPatients 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.
Control
ACTIVE COMPARATORPatients 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.
Interventions
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 .
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles
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.
Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fourth Affiliated Hospital of Guangxi Medical Universitylead
- People's Hospital of Baisecollaborator
- Second Affiliated Hospital of Guangzhou Medical Universitycollaborator
- People's Hospital of Guangxi Zhuang Autonomous Regioncollaborator
- Guilin Medical University, Chinacollaborator
- LiuZhou People's Hospitalcollaborator
- The First People's Hospital of Qinzhoucollaborator
- Wuzhou Red Cross Hospitalcollaborator
- Youjiang Medical College for Nationalitiescollaborator
Study Sites (9)
People's Hospital of Baise
Baise City, Guangxi, 533000, China
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, Guangxi, 533099, China
Guilin Medical University, China
Guilin, Guangxi, 541000, China
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, 541000, China
the Fourth Affiliated Hospital of Guangxi Medical University
Liuchow, Guangxi, China
Second Affiliated Hospital of Guangzhou Medical University
Nanjing, Guangxi, 530000, China
The First People's Hospital of Qinzhou
Qinzhou, Guangxi, 535000, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543000, China
Liuzhou People's Hospital
Liuchow, Other (Non U.s.), 545000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Lu, MD
The Fourth Affiliated Hospital of Guangxi Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2022
First Posted
February 8, 2023
Study Start
December 1, 2022
Primary Completion
November 30, 2024
Study Completion (Estimated)
November 30, 2027
Last Updated
February 8, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- For 2 years started from 12 months after publication of the primary trial report.
- Access Criteria
- Authoritative researchers who provide a methodologically sound proposal for individual participant data meta-analysis.
Complete de-identified patient data set