Radiotherapy Plus Nimotuzumab or Cisplatin in Nasopharyngeal Carcinoma

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Sun Yat-sen University

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Updated on 19 February 2024

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cancer

induction chemotherapy

nasopharyngeal carcinoma

carcinoma

renal function test

epstein-barr virus dna

nimotuzumab

egfr blocker

EGFR

cisplatin

Summary

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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.

Description

Currently, NCCN (National Comprehensive Cancer Network) guidelines recommend induction chemotherapy combined with concurrent chemoradiotherapy as IIA level-evidenced treatment for locally advanced nasopharyngeal carcinoma (stage II-IVa). However, although induction chemotherapy combined with cisplatin based concurrent radiotherapy (CCRT) can significantly improve the survival of patients, the side effects during radiotherapy are more serious.

Previous studies have demonstrated that with a cut-off point of 1500 copies/mL, NPC patients could be segregated into a low-risk subgroup and a high-risk subgroup. Besides, our previous results showed that patients with plasma Epstein-Barr virus (EBV) DNA= 0 copy/mL and complete response/partial response (CR/PR) after induction chemotherapy had a significantly lower risk of disease progression than patients with plasma EBV DNA>0 copy/mL and stable disease /progressive disease (SD/PD),according to Response Evaluation Criteria in Solid Tumors (RECIST). As for these low-risk and chemotheray sensitive patients, it can be considered to reduce the current standard treatment intensity without affecting the survival rate of patients, which reduces the side effects of patients and improve the their life qualities.

Epidermal growth factor (EGFR) is an important therapeutic target for nasopharyngeal carcinoma. A retrospective study suggested that there was no significant difference in the 3-year overall survival between NPC patients who received nimotuzumab / cetuximab plus radiotherapy and those who received standard CCRT. Besides, in terms of hepatorenal toxicity, anti-EGFR drugs showed better safety compared with traditional cisplatin chemotherapy. Up to now, randomized clinical trial about the application of nimotuzumab after IC is still limited.

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

Details

Condition	Carcinoma, vulvar dysplasia and carcinoma, Nasopharyngeal Cancer, Nasopharyngeal Cancer, vulvar dysplasia and carcinoma
Age	18years - 70years
Treatment	RT plus Nimotuzumab, RT plus Cisplatin
Clinical Study Identifier	NCT04456322
Sponsor	Sun Yat-sen University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age 18-70, regardless of sex
	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)
	Patients with pre-treatment plasma EBV DNA<1500 copies/mL
	Patients with plasma EBV DNA= 0 copy/mL and CR/PR according to RECIST after two cycle induction chemotherapy
	ECOG (Eastern Cooperative Oncology Group) score: 0-1
	Women in their reproductive years should ensure that they use contraception during the study period
	Hemoglobin (HGB) 90 g/L, white blood cell (WBC) 4109 /L, platelet (PLT) 100109 /L
	Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 2.5 times the upper limit of normal value (ULN), total bilirubin <2.0ULN
	Renal function: serum creatinine <1.5ULN
	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
	Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
	Receiving radiotherapy or chemotherapy or targeted therapy previously
	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
	Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously
	Patients with significantly lower heart, liver, lung, kidney and bone marrow function
	Severe, uncontrolled medical conditions and infections
	At the same time using other test drugs or in other clinical trials
	Refusal or inability to sign informed consent to participate in the trial
	Other treatment contraindications
	Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct

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Radiotherapy Plus Nimotuzumab or Cisplatin in Nasopharyngeal Carcinoma