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ACTIVE NOT RECRUITING

NCT04456322

PHASE3

Radiotherapy Plus Nimotuzumab or Cisplatin in Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: A Randomized Non-inferiority Trial of Radiotherapy Plus Nimotuzumab or Cisplatin in Patients With Favorable Response to Induction Chemotherapy for Low-risk Locoregionally Advanced-Staged Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

381

Start Date

2020-08-17

Completion Date

2027-05-11

Last Updated

2025-05-14

Healthy Volunteers

Conditions

Nasopharyngeal Carcinoma

Interventions

DRUG

RT plus Nimotuzumab

Nimotuzumab (200mg, once a week during radiotherapy, a total of 7 weeks)

DRUG

RT plus Cisplatin

concurrent cisplatin (100mg/m2, every three weeks,D1,D22,D43 of intensity modulated radiotherapy )

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.

Locations (1)

Sun Yat-sen Universitty Cancer Center

Guangzhou, Guangdong, China