Nimotuzumab combined with chemotherapy and radiation for advanced nasopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Ying Lu, MD — Fourth Affiliated Hospital of Guangxi Medical University
• Study coordinator: Ying Lu, MD
• Email: 1786734840@qq.com
• Phone: +8607723815405

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This trial tests whether adding nimotuzumab to toripalimab with gemcitabine and cisplatin helps people with first-line recurrent or metastatic nasopharyngeal carcinoma.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT06509009

• Immune Sandwich: Induction with Nimotuzumab and Toripalimab Plus Radiotherapy vs Full-Course Immunotherapy for Advanced Nasopharyngeal Cancer

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  Recruiting Phase 3 Sun Yat-sen University · Guangzhou, Guangdong · NCT07706985

• Nimotuzumab plus Immunotherapy and Chemotherapy before surgery for locally advanced head and neck cancer

  This phase 2 trial tests whether adding nimotuzumab to immunotherapy and chemotherapy before surgery helps people with locally advanced head and neck squamous cell carcinoma.

  Recruiting Phase 2 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07601737

• Neoadjuvant chemoradiotherapy with serplulimab and nimotuzumab for resectable locally advanced esophageal squamous cell carcinoma

  This trial will try adding serplulimab and nimotuzumab to preoperative chemoradiotherapy to see if it improves surgical and pathological outcomes for adults with resectable locally advanced esophageal squamous cell carcinoma.

  Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07457528

• Postoperative radiotherapy with nimotuzumab followed by bemcentinib for high-risk head and neck cancer patients who can't take cisplatin

  This study will see if adding nimotuzumab during postoperative radiotherapy followed by bemcentinib can help prevent recurrence in high-risk head and neck cancer patients who are unable to receive cisplatin.

  Recruiting Phase 3 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai · NCT07445048

• Nimotuzumab plus toripalimab and chemotherapy for locally advanced tonsillar cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.