Clinical trial NCT05717790: Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
Official title: Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation and Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage
Keywords: Nimotuzumab
Nasopharyngeal Carcinoma
Induction Chemotherapy
Chemoradiation
Adjuvant Therapy
Lead sponsor: Fourth Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
Collaborators: name: People's Hospital of Baise
name: Second Affiliated Hospital of Guangzhou Medical University
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Guilin Medical University, China
name: LiuZhou People's Hospital
name: The First People's Hospital of Qinzhou
name: Wuzhou Red Cross Hospital
name: Youjiang Medical College for Nationalities
First posted: 2023-02-08
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: overall survival(OS)
timeFrame: 5 years
Secondary outcomes:
measure: Tumor control probability (TCP)
timeFrame: 5 years
measure: Disease-free survival(DFS)
timeFrame: 5 years
measure: Locoregional failure-free survival(LRRFS)
timeFrame: 5 years
measure: Distant Metastasis-free survival(DMFS)
timeFrame: 5 years
measure: Incidence rate of investigator-reported adverse events (AEs)
timeFrame: 5 years
measure: Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
timeFrame: 5 years
Other outcomes:
Locations:
city: Baise
country: China
facility: People's Hospital of Baise
state: Guangxi
city: Baise
country: China
facility: Affiliated Hospital of Youjiang Medical University for Nationalities
state: Guangxi
city: Guilin
country: China
facility: Guilin Medical University, China
state: Guangxi
city: Guilin
country: China
facility: Nanxishan Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Liuzhou
country: China
facility: the Fourth Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Nanjing
country: China
facility: Second Affiliated Hospital of Guangzhou Medical University
state: Guangxi
city: Qinzhou
country: China
facility: The First People's Hospital of Qinzhou
state: Guangxi
city: Wuzhou
country: China
facility: Wuzhou Red Cross Hospital
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Other (Non U.s.)
Study officials:
affiliation: The Fourth Affiliated Hospital of Guangxi Medical University
name: Ying Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: