Radiotherapy Plus Nimotuzumab or Cisplatin in Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase III randomized clinical trial of definitive radiotherapy plus EGFR blocker nimotuzumab versus radiotherapy plus cisplatin(CCRT) for nasopharyngeal carcinoma (NPC) patients with favorable response to induction chemotheray(IC), determining whether radiotherapy combined with nimotuzumab was non-inferior to CCRT and may provide new evidence for individualized comprehensive treatment of locoregionally advanced NPC.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cisplatin; Nimotuzumab

Criteria

Inclusion Criteria:

1. Age 18-70, regardless of sex.

2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage II-IVa (except N3)(according to the 8th American Joint Committee on Cancer[AJCC] edition)

3. Patients with pre-treatment plasma EBV DNA<1500 copies/mL

4. Patients with plasma EBV DNA= 0 copy/mL and CR/PR according to RECIST after two cycle induction chemotherapy

5. ECOG (Eastern Cooperative Oncology Group) score: 0-1

6. Women in their reproductive years should ensure that they use contraception during the study period.

7. Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.

8. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 2.5 times the upper limit of normal value (ULN), total bilirubin <2.0×ULN.

9. Renal function: serum creatinine <1.5×ULN

10. 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. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)

2. Receiving radiotherapy or chemotherapy or targeted therapy previously

3. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.

4. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.

5. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.

6. Severe, uncontrolled medical conditions and infections.

7. At the same time using other test drugs or in other clinical trials.

8. Refusal or inability to sign informed consent to participate in the trial.

9. Other treatment contraindications.

10. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.