Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
- Conditions
- Nasopharyngeal Carcinoma by AJCC V8 Stage
- Interventions
- Registration Number
- NCT05717790
- Lead Sponsor
- Fourth Affiliated Hospital of Guangxi Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 288
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Nimotuzumab arm Intensity-modulated radiotherapy 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. Control Intensity-modulated radiotherapy 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. Experimental: Nimotuzumab arm Nimotuzumab 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. Experimental: Nimotuzumab arm Gemcitabine 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. Experimental: Nimotuzumab arm Cisplatin 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. Control Gemcitabine 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. Control Nimotuzumab 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. Control Cisplatin 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.
- Primary Outcome Measures
Name Time Method overall survival(OS) 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 Outcome Measures
Name Time Method Tumor control probability (TCP) 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.
Disease-free survival(DFS) 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.
Locoregional failure-free survival(LRRFS) 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.
Distant Metastasis-free survival(DMFS) 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.
Incidence rate of investigator-reported adverse events (AEs) 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.
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) 5 years Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Trial Locations
- Locations (9)
Affiliated Hospital of Youjiang Medical University for Nationalities
🇨🇳Baise, Guangxi, China
Guilin Medical University, China
🇨🇳Guilin, Guangxi, China
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Guilin, Guangxi, China
the Fourth Affiliated Hospital of Guangxi Medical University
🇨🇳Liuzhou, Guangxi, China
Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Nanjing, Guangxi, China
People's Hospital of Baise
🇨🇳Baise, Guangxi, China
Wuzhou Red Cross Hospital
🇨🇳Wuzhou, Guangxi, China
Liuzhou People's Hospital
🇨🇳Liuzhou, Other (Non U.s.), China
The First People's Hospital of Qinzhou
🇨🇳Qinzhou, Guangxi, China