Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma

Fourth Affiliated Hospital of Guangxi Medical University

Status: Enrolling

Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage

Treatments: Drug: Cisplatin; Radiation: Intensity-modulated radiotherapy; Drug: Nimotuzumab; Drug: Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT05717790

ZLK3815405

Details and patient eligibility

About

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.

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

288 participants in 2 patient groups

Experimental: Nimotuzumab arm

Experimental group

Description:

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.

Treatment:

Drug: Gemcitabine

Radiation: Intensity-modulated radiotherapy

Drug: Nimotuzumab

Drug: Cisplatin

Control

Active Comparator group

Description:

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.

Treatment:

Drug: Gemcitabine

Radiation: Intensity-modulated radiotherapy

Drug: Nimotuzumab

Drug: Cisplatin