Nimotuzumab combined with chemotherapy and radiation for advanced nasopharyngeal cancer

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

This study is testing if adding a new drug called nimotuzumab to chemotherapy and radiation can help people with advanced nasopharyngeal cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 288 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fourth Affiliated Hospital of Guangxi Medical University (Academic / other)
• Drugs / interventions: chemotherapy, Nimotuzumab
• Locations: 9 sites (Baise City, Guangxi and 8 other locations)
• Trial ID: NCT05717790 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of nimotuzumab, a monoclonal antibody, when used alongside induction chemotherapy and chemoradiation in patients with locoregionally advanced nasopharyngeal carcinoma. The study is multi-center and randomized, focusing on patients diagnosed with stage III-IV non-keratinizing carcinoma. Participants will receive a combination of nimotuzumab, gemcitabine, cisplatin, and intensity-modulated radiotherapy as part of their treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with non-keratinizing nasopharyngeal carcinoma at stage III-IV.

Not a fit: Patients with prior surgery on primary lesions or lymph nodes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could improve outcomes for patients with advanced nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in treating nasopharyngeal carcinoma, suggesting potential for success in this approach.

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.

Where this trial is running

Baise City, Guangxi and 8 other locations

• People's Hospital of Baise — Baise City, Guangxi, China (Recruiting)
• Affiliated Hospital of Youjiang Medical University for Nationalities — Baise City, Guangxi, China (Recruiting)
• Guilin Medical University, China — Guilin, Guangxi, China (Recruiting)
• Nanxishan Hospital of Guangxi Zhuang Autonomous Region — Guilin, Guangxi, China (Recruiting)
• the Fourth Affiliated Hospital of Guangxi Medical University — Liuzhou, Guangxi, China (Recruiting)
• Second Affiliated Hospital of Guangzhou Medical University — Nanjing, Guangxi, China (Recruiting)
• The First People's Hospital of Qinzhou — Qinzhou, Guangxi, China (Recruiting)
• Wuzhou Red Cross Hospital — Wuzhou, Guangxi, China (Recruiting)
• Liuzhou People's Hospital — Liuzhou, Other (Non U.s.), China (Recruiting)

Study contacts

• Principal investigator: Ying Lu, MD — The Fourth Affiliated Hospital of Guangxi Medical University
• Study coordinator: Ying Lu, MD

Conditions Nasopharyngeal Carcinoma by AJCC V8 Stage; Nimotuzumab; Nasopharyngeal Carcinoma; Induction Chemotherapy; Chemoradiation; Adjuvant Therapy